Evidence map›Paper›PMID 26541435›Full record

Trial reportThe British journal of ophthalmology2016

Predicting vision gains with anti-VEGF therapy in neovascular age-related macular degeneration patients by using low-luminance vision.

Ronald E P Frenkel, Howard Shapiro, Ivaylo Stoilov

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00891735 (A Phase III, Double-masked, Multicenter, Randomized, Active Treatment-controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-needed Basis), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 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.

NCT00891735 phase3completednot on this map

A Phase III, Double-masked, Multicenter, Randomized, Active Treatment-controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-needed Basis (PRN) in Patients With Subfoveal Neovascular Age-related Macular Degeneration

TypeinterventionalSponsorGenentech, Inc.Ran2009 to 2012Enrolled1,097ConditionsAge-related Macular DegenerationArmsRanibizumab
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Posterior Retinal Ischemia Correlates With Vision in Patients With Diabetes.Investigative ophthalmology & visual science · 2025
    Observational
  5. Article
  6. Article
  7. Article
  8. Article
  9. Clinical Effect of Tongmai Fuming Decoction on Neovascular Ophthalmopathy.Evidence-based complementary and alternative medicine : eCAM · 2022
    Article
  10. Article
  11. Review
  12. Contrast sensitivity and binocular reading speed best correlating with near distance vision-related quality of life in bilateral nAMD.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2020
    Article
  13. Review
  14. Article
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

3 authors.

Ronald E P FrenkelBascom Palmer Eye Institute, Miami, Florida, USA East Florida Eye Institute, Stuart, Florida, USA Eye Research Foundation, Stuart, Florida, USA.
Howard ShapiroGenentech, Inc, South San Francisco, California, USA.
Ivaylo StoilovGenentech, Inc, South San Francisco, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTo evaluate baseline low-luminance visual acuity (LLVA) as a predictor of visual acuity improvement in patients with neovascular (wet) age-related macular degeneration (wAMD) receiving antivascular endothelial growth factor A (anti-VEGF) therapy.

methodsIn the HARBOR trial, 1084 treatment-naïve patients ≥50 years of age with subfoveal wAMD received intravitreal ranibizumab 0.5 or 2.0 mg monthly or as needed. To measure LLVA, patients read a normally illuminated ETDRS (Early Treatment Diabetic Retinopathy Study) chart with a neutral density filter placed in front of the study eye. Patients were assigned into quartiles based on the magnitude of the difference between best-corrected visual acuity under optimal luminance (BCVA) and LLVA (BCVA-LLVA gap). The association between mean change in BCVA from baseline and BCVA-LLVA gap at baseline was analysed using a general linear model.

resultsA smaller baseline BCVA-LLVA gap predicted significantly higher BCVA gains over 24 months (p<0.0001 at each month; Pearson correlation), even after controlling for baseline BCVA or stratifying by treatment arm. Patients in the smallest baseline BCVA-LLVA gap quartile gained an average of +13.4 letters compared with +2.4 letters for patients in the widest baseline BCVA-LLVA gap quartile. At months 12 and 24, the smallest baseline BCVA-LLVA gap quartile had the highest proportion of ≥15-≥30-letter gain, and the widest baseline BCVA-LLVA gap quartile had the highest proportion of ≥15-/≥30-letter loss (p<0.0001; Fisher's exact test).

conclusionsThe baseline BCVA-LLVA gap is a significant predictor of visual acuity response to anti-VEGF treatment in patients with wAMD. TRIAL REGISTRATION NUMBER: NCT00891735; Post-results.

Indexed as

Visual AcuityAgedAngiogenesis InhibitorsBevacizumabDisease ProgressionDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansIntravitreal InjectionsMacular DegenerationMaleNight VisionRanibizumabRetinal NeovascularizationTomography, Optical CoherenceAngiogenesis InhibitorsBevacizumabRanibizumabVascular Endothelial Growth Factor ADegenerationDrugsMaculaNeovascularisationVision

Identifiers

PMID26541435
PMCPMC4975848

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.