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Diabetic Retinopathy Clinical Trials

Panretinal Photocoagulation Vs Intravitreous Ranibizumab For Proliferative Diabetic Retinopathya Randomized Clinical Trial

Panretinal Photocoagulation Vs Intravitreous Ranibizumab For Proliferative Diabetic Retinopathya Randomized Clinical Trial

Flow of Participants Through a Trial of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy aParticipants were not formally screened prior to obtaining informed consent. bInformation was not collected on specific reasons for exclusion. cParticipants with 2 eyes in the study had 1 eye randomly assigned to receive ranibizumab and 1 eye to receive panretinal photocoagulation. dTwo-year completed visits include those that occurred between 644 and 812 days (between 92 and 116 weeks). Changes in Visual Acuity Over Time for the Overall Cohort, for Eyes With Baseline DME, and for Eyes Without Baseline DME DME indicates diabetic macular edema. Error bars represent 95% CIs. Outlying values were truncated to 3 SDs from the mean; numbers of eyes at each visit week to which this applies are shown for the overall cohort; the numbers of eyes with and without DME are similar. aAt baseline, 2 eyes in each treatment group were missing ocular coherence tomography data and could not be classified as either with or without DME. Continue reading >>

Diabetic Retinopathy Clinical Research Network (drcrnet) Public Web Site

Diabetic Retinopathy Clinical Research Network (drcrnet) Public Web Site

Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema Evaluation of Vitrectomy for Diabetic Macular Edema Study A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema Temporal Variation in Optical Coherence Tomography Measurements of Retinal Thickening in Diabetic Macular Edema A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin) An Observational Study of the Development of Diabetic Macular Edema Following Scatter Laser Photocoagulation The Course of Response to Focal Photocoagulation for Diabetic Macular Edema Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy Evaluation of Visual Acuity Measurements in Eyes with Diabetic Macular Edema Comparison of Time Domain OCT and Spectral Domain OCT Retinal Thickness Measurement in Diabetic Macular Edema A Pilot Study in Individuals with Center-Involved DME Undergoing Cataract Surgery An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved DME Undergoing Cataract Surgery An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy Effect of Diabetes Education during Retinal Ophthalmology Visits on Diabetes Control A Phase II Evaluation of Topical NSAIDs in Eyes with Non Central Involved DME Prompt Panretinal Photocoagulation versus Intravitreal Ranibizumab with Deferred Panr Continue reading >>

Diabetic Retinopathy Clinical Trials

Diabetic Retinopathy Clinical Trials

OCT is an optical ranging and imaging technique first described in 1991 that has since been used successfully to provide high-resolution, micrometer-scale depth imaging in clinical ophthalmology (and other fields). It can be thought of as the optical analogue of ultrasound imaging. For the ocular posterior segment, OCT provides rapid ... Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab This study is an investigator initiated interventional study for subjects with diabetic macular edema that have been previously treated with bevacizumab or ranibizumab. Intravitreal aflibercept 2mg will be given until OCT (ocular coherence tomography) demonstrates an absence of fluid. Continued intravitreal aflibercept 2mg will then take place every 2 months ... Anti-VEGF Treatment for Prevention of PDR/DME Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated ... A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression ... A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Eff Continue reading >>

Allegro Ophthalmics Announces Last Patient Enrolled In Pacific Phase 2b Clinical Trial Of Luminate For Non-proliferative Diabetic Retinopathy

Allegro Ophthalmics Announces Last Patient Enrolled In Pacific Phase 2b Clinical Trial Of Luminate For Non-proliferative Diabetic Retinopathy

Allegro Ophthalmics Announces Last Patient Enrolled in PACIFIC Phase 2b Clinical Trial of Luminate for Non-Proliferative Diabetic Retinopathy SAN JUAN CAPISTRANO, CA October 3, 2016 Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its PACIFIC Phase 2b clinical trial that is evaluating the safety and efficacy of Luminate (ALG-1001) in inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR). We are very pleased to have completed patient enrollment in the PACIFIC trial, said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. There are currently no practical treatment options available for PVD induction in non-proliferative DR, resulting in a significant need for novel, non-surgical treatments that optimize long-term clinical outcomes. We are optimistic that Luminate will continue to show efficacy and provide meaningful therapeutic benefit to patients with diabetic retinopathy and other vitreoretinal diseases. PACIFIC is the third Phase 2 study of Luminate to complete enrollment. Top-line results from PACIFIC are anticipated to be available within the first half of 2017, and those from the DEL MAR Phase 2b trials evaluating Luminate in patients with diabetic macular edema (DME) are expected Q4 2016. PACIFIC is an important study that will broaden and confirm our understanding of this non-surgical option for patients with mild to moderate non-proliferative diabetic retinopathy who may potentially proceed to vision threatening disease over time, said Baruch Kuppermann, M.D., Ph.D., Professor of Ophthalmology and Biomedical Engineering, Chief of the Retina Service, and Vice-Chai Continue reading >>

Diabetic Retinopathy Study (drs)

Diabetic Retinopathy Study (drs)

Does PRP (argon or xenon arc) prevent severe vision loss in eyes with diabetic retinopathy? Patients were included in the study if they had PDR in at least one eye or severe NPDR in both eyes, and had VA of 20/100 or better in each eye. Severe NPDR was defined as the presence at least 3 of the following: 3. Intraretinal microvascular abnormalities (IRMA) in at least 2 contiguous overlapping photographic fields 4. Moderate-to-severe retinal hemorrhages and/or MAs Patients were excluded if they had undergone previous PRP or had a macula-threatening TRD. This was a randomized, prospective multicenter clinical trial. 1742 study subjects were enrolled. One eye from each subject was randomly assigned to PRP and the other eye assigned to no PRP. The PRP eyes were randomized to either argon blue-green laser (800-1600, 500 micron spots) or xenon arc (200-400, 4.5 degree spots). The primary outcome measure was severe vision loss, defined as VA < 5/200 on two consecutive follow-up exams, 4 months apart. PRP reduced the risk of severe vision loss by at least 50% as compared to untreated control eyes. The greatest benefit was seen in eyes with high-risk PDR. Study follow-up was over 5 years. High-risk PDR was defined as any one of the following: 3. NVE disc area with vitreous hemorrhage High-risk PDR was also defined as three or more of the following high-risk characteristics (HRCs): 1. Presence of vitreous hemorrhage or pre-retinal hemorrhage 2. Presence of any active neovascularization 3. Location of neovascularization on or within one disc diameter of the optic disc 4. NVD > 1/3 disc area or NVE > disc area Eyes with high-risk PDR had significantly greater risk of severe visual loss and demonstrated the greatest benefit from PDR. No clear benefit was demonstrated for PRP in eyes Continue reading >>

Diabetic Retinopathy - Global Clinical Trials Review, H2, 2017 - Research And Markets

Diabetic Retinopathy - Global Clinical Trials Review, H2, 2017 - Research And Markets

DUBLIN--( BUSINESS WIRE )--The "Diabetic Retinopathy Global Clinical Trials Review, H2, 2017" clinical trials has been added to Research and Markets' offering. The clinical trial report, Diabetic Retinopathy Global Clinical Trials Review, H2, 2017, provides an overview of Diabetic Retinopathy clinical trials scenario. This report provides top line data relating to the clinical trials on Diabetic Retinopathy. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). The report enhances the decision making capabilities and helps to create an effective counter strategies to gain competitive advantage. The report provides a snapshot of the global clinical trials landscape Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment The Report provides enrollment trends for the past five years Report provides latest news for the past three months Assists in formulating key business strategies with regards to investment Helps in identifying prominent locations for conducting clinical trials which saves time and cost Provides top level analysis of Global Clinical Trials Market which helps in identifying key business opportunities Supports understanding Continue reading >>

Systemic Vegf And Diabetic Retinopathy - Clinical Trials Aiello, Lloyd P. Joslin Diabetes Center, Boston, Ma, United States

Systemic Vegf And Diabetic Retinopathy - Clinical Trials Aiello, Lloyd P. Joslin Diabetes Center, Boston, Ma, United States

Systemic Vegf and Diabetic Retinopathy - Clinical Trials Visual loss from diabetic retinopathy occurs primarily from complications of either abnormal new vessel growth (proliferative diabetic retinopathy, PDR) or increased retinal vascular leakage (diabetic macular edema, DME). We have previously shown that vascular endothelial growth factor (VEGF) is a major mediator of these complications and that VEGF effects are mediated through activation of PKC-Beta. Inhibitors of VEGF and PKC-Beta are entering clinical trials for the treatment of PDR and DME. Both VEGF and PKC-Beta have also been implicated in the progression of early stages of diabetic retinopathy. To date, assessment of VEGF in patients has been limited due to either the need to obtain intraocular fluid samples or inadequate sensitivity of blood assays. The PI has developed a highly sensitive VEGF ELIZA which can readily detect the low basal levels of VEGF in both blood and urine. Preliminary data suggest that peripheral VEGF concentration may reflect retinopathy status and are effected by various physiologic processes. If VEGF in the blood or serum correlate with retinopathy level then measurement of VEGF from these peripheral fluids might be useful in identifying patients at risk of developing PDR or DME and might help in monitoring responses to anti-VEGF therapies. In addition, we have collaboratively developed techniques to specifically measure activated PKC-Beta in human monocytes. Thus, the specific aims: 1) Determine the correlation between peripheral VEGF, ocular VEGF and diabetic retinopathy in a cross- sectional clinical study; 2) Determine the correlation between activated PKC-Beta in monocytes and diabetic retinopathy in a cross- sectional clinical study; 3) Determine the role of VEGF in the progre Continue reading >>

Report From The Nei/fda Diabetic Retinopathy Clinical Trial Design And Endpoints Workshop | Iovs | Arvo Journals

Report From The Nei/fda Diabetic Retinopathy Clinical Trial Design And Endpoints Workshop | Iovs | Arvo Journals

Report From the NEI/FDA Diabetic Retinopathy Clinical Trial Design and Endpoints Workshop Joslin Diabetes Center, Boston, Massachusetts, United States University of Michigan, Ann Arbor, Michigan, United States Northwestern University, Chicago, Illinois, United States National Eye Institute, Bethesda, Maryland, United States Correspondence: Frederick L. Ferris III, National Eye Institute, National Institutes of Health, Bethesda, MD, USA; [email protected] . Invited speakers and discussants are listed on page 5128. Investigative Ophthalmology & Visual Science October 2016, Vol.57, 5127-5142. doi:10.1167/iovs.16-20356 Report From the NEI/FDA Diabetic Retinopathy Clinical Trial Design and Endpoints Workshop You will receive an email whenever this article is corrected, updated, or cited in the literature. You can manage this and all other alerts in My Account Prashant Nair, Lloyd Paul Aiello, Thomas W. Gardner, Lee M. Jampol, Frederick L. Ferris III; Report From the NEI/FDA Diabetic Retinopathy Clinical Trial Design and Endpoints Workshop. Invest. Ophthalmol. Vis. Sci. 2016;57(13):5127-5142. doi: 10.1167/iovs.16-20356. ARVO (1962-2015); The Authors (2016-present) On June 26, 2015, the National Eye Institute (NEI) and the US Food and Drug Administration (FDA) together held the second workshop on diabetic retinopathy (DR) clinical trial design and endpoints at the National Institutes of Health in Bethesda, Maryland. Diabetic retinopathy, a diabetes-related eye disease, is a leading cause of blindness among adult Americans. The condition is characterized by pathologic changes in blood vessels in the retina, including abnormal growth, swelling, and blockage of retinal blood vessels, leakage of fluid, and progressive loss of vision, if unchecked. Multiple clinical stages of th Continue reading >>

Diabetic Retinopathy Study (drs)

Diabetic Retinopathy Study (drs)

Resources Journal Club Retina Diabetic Retinopathy Study (DRS) To determine the role of PRP in reducing VA loss in advanced DR Multi-centre, randomised trial: Argon or Xenon PRP versus no treatment Diabetic Retinopathy Study Research Group. Preliminary report on effects of photocoagulation therapy. Am J Ophthalmology 1976; 81:383-396. The Diabetic Retinopathy Study (DRS) was the first major initiative of the National Eye Institute. It was a multi-centre, randomized clinical trial designed to evaluate the safety and efficacy of panretinal photocoagulation (PRP) in reducing the risk of vision loss and blindness in patients with advanced diabetic retinopathy. 1758 patients were enrolled between 1972 and 1975. Patients were eligible if they had best corrected visual acuity of 20/100 or better in each eye and the presence of proliferative diabetic retinopathy in at least one eye or severe nonproliferative retinopathy in both eyes. They could not have had prior treatment with photocoagulation or pituitary ablation, and both eyes had to be suitable for photocoagulation. All eligible patients were younger than 70 years, and the examining physician assessed the outlook for survival and availability for 5 years of followup to be good. One eye of each patient was randomly assigned to immediate photocoagulation and the other to followup without treatment, regardless of the course followed by either eye. The eye chosen for photocoagulation was randomly assigned to either of two treatment techniques, one using an argon laser and the other a xenon arc photocoagulator. Patients were followed at 4-month intervals according to a protocol that provided for measurement of best corrected visual acuity. Treatment was usually completed in one or two sittings and included scatter (panretinal) Continue reading >>

Retina Today - Update On The Diabetic Retinopathy Clinical Research Network (july/august 2010)

Retina Today - Update On The Diabetic Retinopathy Clinical Research Network (july/august 2010)

Update on the Diabetic Retinopathy Clinical Research Network Recent data and status of some ongoing DRCR.net protocols. This information was provided by Drs. Solomon andBressler as individuals, not on behalf of the DRCR.net. The Diabetic Retinopathy Clinical ResearchNetwork (DRCR.net) is a collaborative networkfunded by the National Institutes ofHealth to facilitate multicenter clinicalresearch on diabetic retinopathy, diabetic macularedema (DME), and related conditions, primarilythrough the design and execution of clinical trials.Established in 2002 with funds currently awardedthrough 2013 from the National Eye Institute (NEI)and also from funding by the National Institute ofDiabetes and Digestive and Kidney Diseases (NIDDK),the DRCR.net has promoted the collaboration ofcommunity- and academic-based practices withindustry to pursue multicenter research initiativesthat otherwise might not be undertaken. TheNetwork currently consists of approximately 200clinical sites throughout the United States, Europe,and Asia, with nearly 700 participating physicians.More than 3,500 patients have enrolled in at least oneof the more than 15 DRCR.net clinical trials. Followingis a review of some of the Network clinical trials thathave had an impact on the current management ofdiabetic retinopathy and DME, as well as an updateon what is on the horizon for the DRCR.net. A Randomized Trial Comparing IntravitrealTriamcinolone Acetonide to Focal/GridPhotocoagulation for Diabetic Macular Edema.1,2 Manyof the current treatment paradigms for the managementof DME have been derived from the EarlyTreatment Diabetic Retinopathy Study (ETDRS), a randomized,prospective clinical trial that demonstratedthat eyes with macular edema treated with focal/gridlaser were less likely to have moderate vision Continue reading >>

Assessing Possible Late Treatment Effectsin Stopping A Clinical Trial Early: A Case Study. Diabetic Retinopathy Study Report No. 9

Assessing Possible Late Treatment Effectsin Stopping A Clinical Trial Early: A Case Study. Diabetic Retinopathy Study Report No. 9

Assessing possible late treatment effectsin stopping a clinical trial early: A case study. Diabetic retinopathy study report no. 9 Author links open overlay panel FredEderer Get rights and content Suppose a fixed-sample trial in a disease with a long response time shows a statistically significant benefit of the experimental treatment before patients have completed the planned follow-up period. The question may then arise-and did arise in the Diabetic Retinopathy Study (DRS)whether the observed early benefit of treatment may be offset at some time in the future by the subsequent development of harmful treatment effects. If this question raises serious concerns, then the investigators are faced with a dilemma.If the trial is stopped because of the observed early treatment benefit and thetreatment is administered to the untreated control group as well as to patients outside the study, and if the treatment is later found to have deleterious effects, then it may ultimately do more harm than good to patients. Moreover, the fact that the treatment is harmful may never become known. If, on the other hand, the trial is not stopped and the treatment proves to have no deleterious effects, then the control group and patients outside the study would be harmed because the treatment was withheld.We show how, in the DRS, this very problem was formulated and resolved. Firsta severe, delayed harmful treatment effect was postulated. Projections based on this postulation showed that the early gains were so great that they were unlikely to be offsetever. Based in part on these projections, the following decisions were made: (a) the study protocol would be changed so as to allow treatment of the untreated control group, and (b) patients would continue to be followed in order to make possib Continue reading >>

Diabetic Retinopathy - Global Clinical Trials Review, H2, 2017 - Research And Markets

Diabetic Retinopathy - Global Clinical Trials Review, H2, 2017 - Research And Markets

Diabetic Retinopathy - Global Clinical Trials Review, H2, 2017 - Research and Markets The "Diabetic Retinopathy Global Clinical Trials Review, H2, 2017" clinical trials has been added to Research and Markets' offering. The clinical trial report, Diabetic Retinopathy Global Clinical Trials Review, H2, 2017, provides an overview of Diabetic Retinopathy clinical trials scenario. This report provides top line data relating to the clinical trials on Diabetic Retinopathy. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). The report enhances the decision making capabilities and helps to create an effective counter strategies to gain competitive advantage. The report provides a snapshot of the global clinical trials landscape Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment The Report provides enrollment trends for the past five years Report provides latest news for the past three months Assists in formulating key business strategies with regards to investment Helps in identifying prominent locations for conducting clinical trials which saves time and cost Provides top level analysis of Global Clinical Trials Market which helps in id Continue reading >>

Promising New Drug For Diabetic Retinopathy Hits Clinical Trials

Promising New Drug For Diabetic Retinopathy Hits Clinical Trials

Promising new drug for diabetic retinopathy hits clinical trials Promising new drug for diabetic retinopathy hits clinical trials A completely new treatment for diabetic retinopathy has started being tested in people for the first time. The first-in-man trials of experimental drug KVD001 began this month, focussing on assessing the safety and tolerability of the drug in treating diabetic macular oedema (a particular type of retinopathy). The trials are being conducted at the world renowned Beetham Eye Institute (part of the Joslin Diabetes Centre at Harvard Medical School in Boston) and recruitment will gradually roll out through five centres in the US. The company behind the drug, KalVista, is a small biotechnology company based near Southampton. JDRF has been working with KalVista on the drug for a number of years, and indeed JDRF supported the academic research that identified the biological pathway the drug is designed to target. The only drug currently licensed specifically for treating diabetic macular oedema, is ranizumab (brand name Lucentis). This drug is designed to target a molecule called vascular endothelial growth factor and so prevent the disordered growth of blood vessels that contributes to vision loss. While treatment with Lucentis has been able to help many people with diabetic macular oedema, it doesnt work for everyone. KVD001 is a type of molecule called a plasma kallikrein inhibitor, and targets a different biological pathway to Lucentis so KalVistas new drug may be able to help those for whom Lucentis does not work. Rachel Connor, Head of Research Communication at JDRF in the UK said: As complications of living with type 1 go, vision loss is one of the most feared. JDRFs research strategy prioritises work to understand diabetic retinopathy and d Continue reading >>

Researchers Consider Meaningful Endpoints In Diabetic Retinopathy Clinical Trials

Researchers Consider Meaningful Endpoints In Diabetic Retinopathy Clinical Trials

Researchers consider meaningful endpoints in diabetic retinopathy clinical trials As technology improves, physicians rely on OCT for retinal thickness, as well as color photography, fluorescein angiography Madison, WIThe visual and morphology measurements used as endpoints in a clinical trial have both advantages and disadvantages that must be balanced by their value in achieving the goals of the study, according to Ronald Danis, MD. To obtain valid clinical trial data, the endpoints must be meaningful, measurable, and consistent with study goals, said Dr. Danis, professor, Department of Ophthalmology and Visual Sciences, and director of the Fundus Photograph Reading Center, University of Wisconsin, Madison. A measurable endpoint is one that is reliable, and the signal has to be greater than the noise or the biological variation of the disease. A meaningful endpoint is one in which there is a direct relationship or strong association with the relevant functional outcomes of the disease, he said. Noting how endpoints have changed as technology has advanced, Dr. Danis said that blindness (defined as a visual acuity of 5/200) was an endpoint in the Diabetic Retinopathy Study conducted in the 1970s, and the 15-letter threshold for vision loss became established as the primary outcome in the 1980s with the Early Treatment Diabetic Retinopathy Study (ETDRS). And in recent studies, such as the Lilly PK-DMES trial conducted in the 1990s, vision has not been an endpoint at all because the goal is to have an impact on the disease before vision loss occurs. However, overall, visual acuity remains a robust endpoint in many trials of diabetic retinopathy, and best-corrected acuity by the ETDRS acuity chart with standardized refraction measured in masked fashion is the gold standard Continue reading >>

The Landmark Trials: Diabetic Retinopathy Study And Early Treatment Diabetic Retinopathy Study - Pan-retinal Photocoagulation And Other Forms Of Laser Treatment And Drug Therapies For Non-proliferative Diabetic Retinopathy: Systematic Review And Economic Evaluation - Ncbi Bookshelf

The Landmark Trials: Diabetic Retinopathy Study And Early Treatment Diabetic Retinopathy Study - Pan-retinal Photocoagulation And Other Forms Of Laser Treatment And Drug Therapies For Non-proliferative Diabetic Retinopathy: Systematic Review And Economic Evaluation - Ncbi Bookshelf

The search question posed in the commissioning brief was: What is the clinical and cost-effectiveness of pan-retinal laser treatment in the management of non-proliferative (pre-proliferative) diabetic retinopathy (NPDR)? The patient groups specified were those with early stages of NPDR (Level R2) versus the control or comparator treatment of PRP at PDR (Level R3), in any appropriate setting. Our scoping searches gave a very low retrieval of studies that would be relevant to this search question, but did show that there were recent developments in types of laser and in the use of laser and drug combinations. Therefore, in the draft protocol we proposed a wider scope for this Technology Assessment Report than had been envisaged in the commissioning brief. This was approved by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) after being supported by the external referees. The decision problem was subsequently expanded to become: Treatment of non-proliferative diabetic retinopathy: a review of pan-retinal photocoagulation, other forms of laser treatment, and combinations of photocoagulation and anti-VEGF drugs or inject steroids. However, the broader searches revealed that there were no RCTs that compared patients at the NPDR level to those at later stages of PRP. Indeed, the most relevant and largest study done addressing the timing of PRP laser in the treatment of DR, the ETDRS, grouped together patients with moderate to severe NPDR and early PDR, and did not report outcomes on these groups separately. Therefore, it seemed likely that a trial to address the original research question was needed, and, in order to inform a future study on PRP treatment of patients at the NPDR stage, we decided to further broaden the searches to capture all forms of curr Continue reading >>

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