Evidence map›Paper›PMID 28102456›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2017

Efficacy and safety of a fixed bimonthly ranibizumab treatment regimen in eyes with neovascular age-related macular degeneration: results from the RABIMO trial.

Nicolas Feltgen, Thomas Bertelmann, Mirko Bretag, Sebastian Pfeiffer, Reinhard Hilgers, Josep Callizo, Lena Goldammer, Sebastian Bemme, Hans Hoerauf

Abstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 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.

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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Long-term remission and incidence of recurrence of neovascularization in intravitreal injection treated exudative age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  6. Article
  7. Article
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  9. Observational
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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

9 authors.

Nicolas FeltgenDepartment of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany. nicolas.feltgen@med.uni-goettingen.de.ORCID http://orcid.org/0000-0002-6857-3003
Thomas BertelmannDepartment of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
Mirko BretagDepartment of Ophthalmology, Carl-Thiem-Klinikum gGmbH, Cottbus, Germany.
Sebastian PfeifferInstitute for Clinical Research GmbH, Georg-August-University, Goettingen, Germany.
Reinhard HilgersInstitute for Medical Statistics, Georg-August-University, Goettingen, Germany.
Josep CallizoDepartment of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
Lena GoldammerEye Centre Celle, Celle, Germany.
Sebastian BemmeDepartment of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
Hans HoeraufDepartment of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate prospectively the efficacy and safety of a fixed bimonthly ranibizumab treatment regimen (RABIMO) in eyes with neovascular age-related macular degeneration (nAMD) and to compare these results with a pro re nata (PRN) treatment scheme.

methodsThis was a 12-month, phase IV, single center, randomised, non-inferiority study. Following three initial monthly injections, patients were randomised to receive either ranibizumab bimonthly (RABIMO group) or ranibizumab PRN (PRN group) (n = 20 each). Main outcome measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), number of injections, and adverse events (AEs).

resultsBCVA [median (interquartile range, IQR)] increased significantly in both groups after 12 months [RABIMO group +8.5 (14); PRN group +6.5 (16) ETDRS letters] when compared to baseline (p < 0.0001; p = 0.0085). At month 12, the RABIMO treatment regimen was non-inferior to the PRN scheme (∆BCVA = 3.5 ETDRS letters; p < 0.0001). CRT was significantly reduced in both groups after the 12-month study period (p < 0.0001 each), with no significant difference between groups (p = 0.6772). Number of overall injections [median (IQR)] was 8 (0) in the RABIMO versus 4 (5) in the PRN group (p = 0.0037). Three patients in the RABIMO group received one additional unscheduled injection. We observed no significant differences between groups in the number of patients with reported SAEs/AEs (RABIMO group n = 6/15; PRN group n = 7/13) (p = 0.7357/p = 0.4902).

conclusionsWe found no evidence of significant functional or anatomical differences between the RABIMO and PRN treatment regimens. However, the RABIMO group's number of injections was twice as high as the PRN group's (protocol-driven). In light of potential side effects, the fixed bimonthly treatment regimen might not be advisable for routine clinical care, but it might be a worthwhile treatment option if monthly monitoring is not possible. Eudra-CT number: 2009-017324-11.

Indexed as

Visual AcuityAgedAged, 80 and overAngiogenesis InhibitorsDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansIntravitreal InjectionsMacula LuteaMaleProspective StudiesRanibizumabTime FactorsTomography, Optical CoherenceAngiogenesis InhibitorsRanibizumabAge-related macular degenerationAMDOptical coherence tomographyPRNRanibizumabTreatment schedule

Identifiers

PMID28102456

What OpenQuestion holds

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Registered trials

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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.