Evidence map›Paper›PMID 23370902›Full record

Trial reportJAMA ophthalmology2013

Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy.

Diabetic Retinopathy Clinical Research Network*

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in JAMA ophthalmology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00996437 (An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy), which is not on this map. Cited by 53 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT00996437 phase2 / phase3completednot on this map

An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy

TypeinterventionalSponsorJaeb Center for Health ResearchRan2010 to 2013Enrolled261ConditionsVitreous Hemorrhage, Proliferative Diabetic RetinopathyArmsRanibizumab, Saline
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. A systematic review and meta-analysis of the effect of intravitreal VEGF inhibitors on cardiorenal outcomes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
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  19. Vitreous hemorrhage - Causes, diagnosis, and management.Indian journal of ophthalmology · 2023
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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

1 author.

Diabetic Retinopathy Clinical Research Network*Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350, Tampa, FL 33647, USA.

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
UIC K12 Independent Clinical Vision Scientist Development ProgramK12EY021475 · NEI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI ALI R DJALILIAN, CHARLOTTE E JOSLIN · 2011 to 2026
$6.7M
Diabetic Retinopathy Clinical Research Network Operations CenterU10EY018817 · NEI · JOHNS HOPKINS UNIVERSITY · PI BRESSLER, NEIL MICHAEL · 2009 to 2013
$769k
NEI NIH HHS EY14231NEI NIH HHS EY18817NEI NIH HHS K12 EY021475NEI NIH HHS U10 EY014231NEI NIH HHS U10 EY018817NEI NIH HHS UG1 EY014231
6 · The paper itself

Abstract

importanceVascular endothelial growth factor plays a role in proliferative diabetic retinopathy (PDR). Intravitreal injection of saline has been shown potentially to lead to improved visual acuity compared with observation alone in eyes with vitreous hemorrhage. Therefore, it is important to determine if intravitreal anti-vascular endothelial growth factor can reduce vitrectomy rates (and risks associated with vitrectomy) compared with saline for vitreous hemorrhage from PDR that precludes placement or confirmation of complete panretinal photocoagulation.

objectiveTo evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage from PDR.

designPhase 3, double-masked, randomized, multicenter clinical trial. Data reported were collected from June 2010 to March 2012 and include 16 weeks of follow-up.

settingCommunity-based and academic-based ophthalmology practices specializing in retinal diseases.

participantsTwo hundred sixty-one eyes of 261 study participants, who were at least 18 years of age with type 1 or type 2 diabetes mellitus. Study eyes had vitreous hemorrhage from PDR precluding panretinal photocoagulation completion.

interventionEyes were randomly assigned to 0.5-mg intravitreal ranibizumab (n = 125) or intravitreal saline (n = 136) at baseline and 4 and 8 weeks.

main outcome measureCumulative probability of vitrectomy within 16 weeks.

resultsCumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab vs 17% with saline (difference, 4%; 95% CI, -4% to 13%) and of complete panretinal photocoagulation without vitrectomy by 16 weeks was 44% and 31%, respectively (P = .05). The mean (SD) visual acuity improvement from baseline to 12 weeks was 22 (23) letters and 16 (31) letters, respectively (P = .04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17%, respectively (P = .01). One eye developed endophthalmitis after saline injection. CONCLUSIONS AND RELEVANCE: Overall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR. Short-term secondary outcomes including visual acuity improvement, increased panretinal photocoagulation completion rates, and reduced recurrent vitreous hemorrhage rates suggest biologic activity of ranibizumab. Long-term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab injection are different than observation alone cannot be determined from this study.

trial registrationThe study is listed on www.clinicaltrials.gov, under identifier NCT00996437 (website registration date October 14, 2009).

Indexed as

AgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic RetinopathyDouble-Blind MethodFemaleFollow-Up StudiesHumansIntravitreal InjectionsMaleMiddle AgedRanibizumabRecurrenceRetinal NeovascularizationAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedRanibizumabSodium Chloride

Identifiers

PMID23370902
PMCPMC4217122

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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.