Evidence map›Paper›PMID 32112140›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2020

Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial.

Ira Seibel, Daniela Vollhardt, Aline I Riechardt, Matus Rehak, Sabine Schmied, Petra Schiller, Oliver Zeitz, Martin Hellmich, Antonia M Joussen

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Guideline
  2. 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
    Pooled it
  3. Trial
  4. Observational
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Radiation Retinopathy: Detection and Management Strategies.Clinical ophthalmology (Auckland, N.Z.) · 2021
    Review
  12. Review
  13. 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

9 authors at 2 institutions in 1 country.

Ira SeibelDepartment of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Daniela VollhardtDepartment of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Aline I RiechardtDepartment of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Matus RehakDepartment of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Sabine SchmiedClinical Trial Centre Cologne (CTCC), University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.
Petra SchillerInstitute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Bachemer Str. 86, 50931, Cologne, Germany.
Oliver ZeitzDepartment of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Martin HellmichInstitute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Bachemer Str. 86, 50931, Cologne, Germany.
Antonia M JoussenDepartment of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany. antonia.joussen@charite.de.
Charité - Universitätsmedizin Berlin · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo demonstrate superiority of intravitreal ranibizumab 0.5 mg compared to focal and peripheral laser treatment in patients with radiation retinopathy for choroidal melanoma.

methodsInclusion criteria were as follows: patients with radiation retinopathy and visual acuity impairment due to radiation maculopathy accessible for laser therapy, age ≥ 18 years, and BCVA less than 20/32. The main objective was to study the change in best-corrected visual acuity (BCVA) over 6 months from ranibizumab 0.5 mg (experimental) compared to focal laser of the macula and panretinal laser treatment of the ischemic retina (control) in patients with radiation retinopathy in choroidal melanoma. The secondary objectives of the radiation retinopathy study were to compare functional and anatomical results between ranibizumab and laser group over 12 months and to measure the frequency of vitreous hemorrhage and rubeosis iridis.

resultsThe intention-to-treat analysis included 31 patients assigned to ranibizumab (n = 15) or laser treatment (n = 16). In terms of BCVA at month 6, ranibizumab was superior to laser treatment, with an advantage of 0.14 logMAR, 95% CI 0.01 to 0.25, p = 0.030. The positive effect of ranibizumab disappeared after treatment was discontinued. Similar results without statistically significant difference were found with respect to macular thickness. In both groups, no change was observed at month 6 in the size of ischemia in the macula or periphery compared to baseline. There was 1 case of vitreous hemorrhage in the laser group and no case of rubeosis iridis over time.

conclusionsThis study showed a statistically significant improvement in visual acuity and clear superiority of ranibizumab compared to laser treatment up to 26 weeks, but this effect disappeared at week 52 after completion of intravitreal treatment. Ranibizumab and PRP are considered equivalent in terms of the non-appearance of proliferative radiation retinopathy during the study.

trial registrationEudraCT Number: 2011-004463-69.

Indexed as

Visual AcuityAgedAngiogenesis InhibitorsFemaleFollow-Up StudiesHumansIntravitreal InjectionsLaser CoagulationMaleMiddle AgedProspective StudiesRadiation InjuriesRanibizumabRetinaRetinal DiseasesSingle-Blind MethodAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor AIntravitreal therapyLaser photocoagulationRadiation retinopathyRanibizumabUveal melanoma

Identifiers

PMID32112140
PMCPMC7575494
OpenAlexW3006928988

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.