CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Ranibizumabdrug
Likely dose
Ranibizumab 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02034006
NCT02034006Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jan 13, 2014·Updated Feb 18, 2019

In Brief

A Phase 3 clinical trial evaluating Ranibizumab for Choroidal Neovascularization Secondary to Pathologic Myopia. Completed, enrolled 200 participants across 31 sites.

Detailed Summary

The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChoroidal Neovascularization Secondary to Pathologic Myopia
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 13, 2014
Enrollment StartJun 10, 2014
Primary CompletionJul 15, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.5 years ago

Interventions

Ranibizumabdrug

All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.