Evidence map›Paper›PMID 30680452›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2019

OLIMPIC: a 12-month study on the criteria driving retreatment with ranibizumab in patients with visual impairment due to myopic choroidal neovascularization.

Federico Ricci, Giovanni Staurenghi, Monica Varano, Chiara Eandi, Tommaso Lupieri Sinibaldi, Laura Colombo, Marta Bartezaghi, Stefania Bassanini

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02034006 (A 12-month, Open-label, Interventional, Multicentre Study to Investigate the Current Criteria Driving Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 47% 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.

NCT02034006 phase3completednot on this map

A 12-month, Open-label, Interventional, Multicentre Study to Investigate the Current Criteria Driving Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2016Enrolled200ConditionsChoroidal Neovascularization Secondary to Pathologic MyopiaArmsRanibizumab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

8 authors at 5 institutions in 1 country.

Federico RicciRetina Diseases Unit, Referral Center for Diagnosis and Therapy of AMD and Sight Threatening Retinal Diseases, PTV Foundation/Tor Vergata University, Viale Oxford, 81, 00133, Rome, Italy. rccfrc00@gmail.com.
Giovanni StaurenghiDepartment of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.
Monica VaranoIRCCS-Fondazione Bietti, Rome, Italy.
Chiara EandiDepartment of Surgical Sciences, Eye Clinic, University of Torino, Via Juvarra 19, 10122, Turin, Italy.
Tommaso Lupieri SinibaldiNovartis Farma SpA, Largo Umberto Boccioni 1, 21040, Origgio, VA, Italy.
Laura ColomboNovartis Farma SpA, Largo Umberto Boccioni 1, 21040, Origgio, VA, Italy.
Marta BartezaghiNovartis Farma SpA, Largo Umberto Boccioni 1, 21040, Origgio, VA, Italy.
Stefania BassaniniNovartis Farma SpA, Largo Umberto Boccioni 1, 21040, Origgio, VA, Italy.
Novartis (Italy) · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITLuigi Sacco Hospital · ITPoliclinico Tor Vergata · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate criteria driving retreatment with ranibizumab in Italian patients with myopic choroidal neovascularization (mCNV).

methodsOLIMPIC was a 12-month, phase IIIb, open-label study. Patients with active mCNV were treated with ranibizumab 0.5 mg according to the European label. The study assessed local criteria in Italy driving retreatment decisions with ranibizumab; and the efficacy, safety, and tolerability of ranibizumab.

resultsThe mean (standard deviation [SD]) age of treated patients (N = 200) was 61.8 (12.7) years; range 22-85 years. The multivariate regression model indicated that presence of active leakage (odds ratio [OR] 95% confidence interval [CI]: 11.30 [1.03-124.14]), presence of intraretinal fluid (OR [95%CI]: 28.21 [1.55-513.73]), and an improvement in best-corrected visual acuity (BCVA) from baseline < 10 letters (OR [95%CI]: 17.60 [1.39-222.75]) were the factors with the greatest effect on retreatment with ranibizumab. The mean (SD) BCVA gain from baseline to month 12 was 8.4 (12.8) letters (P < 0.0001). The mean (SD) number of injections was 2.41 (1.53); range 1-9. Ocular and non-ocular adverse events were reported in 41 (20.5%) and 30 (15.0%) patients, respectively.

conclusionsIndividualized treatment with ranibizumab was effective in improving BCVA in patients with mCNV over 12 months. Both anatomical and functional variables had significant effects on causing retreatment. There were no new safety findings.

trial registrationwww.ClinicalTrials.Gov (NCT No: NCT02034006).

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsChoroidal NeovascularizationFemaleHumansIntravitreal InjectionsMaleMiddle AgedMyopia, DegenerativeProspective StudiesRanibizumabRetreatmentSubretinal FluidVascular Endothelial Growth Factor AAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor AVEGFA protein, humanChoroidal neovascularizationPathologic myopiaRanibizumabRetreatment criteriaVisual acuityVisual impairment

Identifiers

PMID30680452
OpenAlexW2912636642

What OpenQuestion holds

Textmetadata
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.