Evidence map›Paper›PMID 30096354›Full record

Trial reportOphthalmology2019

Rationale and Application of the Protocol S Anti-Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy.

Jennifer K Sun, Adam R Glassman, Wesley T Beaulieu, Cynthia R Stockdale, Neil M Bressler, Christina Flaxel, Jeffrey G Gross, Michel Shami, Lee M Jampol, Diabetic Retinopathy Clinical Research Network

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01489189 (Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy), which is not on this map. Cited by 57 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 3 pooled it
10.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01489189 phase3completednot on this map

Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

TypeinterventionalSponsorJaeb Center for Health ResearchRan2012 to 2018Enrolled305ConditionsProliferative Diabetic RetinopathyArmsPrompt Panretinal Photocoagulation, 0.5-mg Ranibizumab, Deferred panretinal photocoagulation
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 3 syntheses or guidelines pooled it, 114 citations in OpenAlex.

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  13. Diabetic retinopathy-recommendations for screening and treatment.Wiener medizinische Wochenschrift (1946) · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Jennifer K SunJoslin Diabetes Center, Beetham Eye Institute, Department of Ophthalmology, Harvard University, Boston, Massachusetts.
Adam R GlassmanJaeb Center for Health Research, Tampa, Florida.
Wesley T BeaulieuJaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat8@jaeb.org.
Cynthia R StockdaleJaeb Center for Health Research, Tampa, Florida.
Neil M BresslerWilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Christina FlaxelCasey Eye Institute, Portland, Oregon.
Jeffrey G GrossCarolina Retina Center, PA, Columbia, South Carolina.
Michel ShamiTexas Retina Associates, Lubbock, Texas.
Lee M JampolFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
Diabetic Retinopathy Clinical Research Network
Jaeb Center for Health Research · USCarolina Retina Center · USJohns Hopkins University · USJoslin Diabetes Center · USNorthwestern University · USTexas Retina Associates (United States) · US

Funding

DIABETIC RETINOPATHY CLINICAL RESEARCH NETWORK COORDINATING CENTERU10EY014231 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI GLASSMAN, ADAM R · 2002 to 2018
$91.2M
DRCR Retina NetworkUG1EY014231 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI Adam R Glassman, DANIEL F MARTIN · 2019 to 2026
$75.4M
Diabetic Retinopathy Clinical Research Network Chair GrantU10EY023207 · NEI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI JAMPOL, LEE M · 2014 to 2018
$1.8M
Diabetic Retinopathy Clinical Research Network Operations CenterU10EY018817 · NEI · JOHNS HOPKINS UNIVERSITY · PI BRESSLER, NEIL MICHAEL · 2009 to 2013
$769k
NEI NIH HHS U10 EY014231NEI NIH HHS U10 EY018817NEI NIH HHS U10 EY023207NEI NIH HHS UG1 EY014231
6 · The paper itself

Abstract

purposeTo present the rationale, guidelines, and results of ranibizumab treatment for proliferative diabetic retinopathy (PDR) in Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S.

designPost hoc analyses from a randomized clinical trial.

participantsThree hundred five participants (394 study eyes) having PDR without prior panretinal photocoagulation (PRP).

methodsIntravitreous ranibizumab (0.5 mg) versus PRP for PDR. Ranbizumab-assigned eyes (n = 191) received monthly injections for 6 months unless resolution was achieved after 4 injections. After 6 months, injections could be deferred if neovascularization was stable over 3 consecutive visits (sustained stability). If neovascularization worsened, monthly treatment resumed. Panretinal photocoagulation could be initiated for failure or futility criteria.

main outcome measuresNeovascularization status through 2 years.

resultsAt 1 month, 19% (35 of 188) of ranibizumab-assigned eyes showed complete neovascularization resolution and an additional 60% (113) showed improvement. At 6 months, 52% (80 of 153) showed neovascularization resolution, 3% (4) were improved, 37% (56) were stable, and 8% (13) had worsened since the last visit. Among eyes with versus without resolved neovascularization at 6 months, the median (interquartile range) number of injections between 6 months and 2 years was 4 (1-7; n = 73) versus 7 (4-11; n = 67; P < 0.001). Injections were deferred in 68 of 73 eyes (93%) meeting sustained stability at least once during the study; 62% (42 of 68) resumed injections within 16 weeks after deferral. At 2 years, 43% (66 of 154) showed neovascularization resolution, 5% (7) showed improvement, 23% (36) were stable, and 27% (42) had worsened since the last visit. Only 3 eyes met criteria for failure or futility through 2 years.

conclusionsThe DRCR.net treatment algorithm for PDR can provide excellent clinical outcomes through 2 years for patients initiating anti-vascular endothelial growth factor (VEGF) therapy for PDR. When choosing between anti-VEGF and PRP as first-line therapy for PDR, treatment decisions should be guided by consideration of the relative advantages of each therapeutic method and anticipated patient compliance with follow-up and treatment recommendations.

Indexed as

AlgorithmsAdultAngiogenesis InhibitorsClinical ProtocolsDiabetic RetinopathyFemaleFollow-Up StudiesHumansIntravitreal InjectionsLaser CoagulationMaleMiddle AgedRanibizumabRetinal NeovascularizationVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID30096354
PMCPMC6916649
OpenAlexW2885537851

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.