CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
RBM-007 Injectable Solution +2 moredrug
Likely dose
Not stated in 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/NCT04200248
NCT04200248Phase 2Completed
CompareCT.gov

A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of RBM-007 Monotherapy and RBM-007 in Combination With Eylea® Compared to Eylea® Monotherapy

Ribomic USA Inc·interventional·Posted Dec 16, 2019·Updated Jun 8, 2023

In Brief

A Phase 2 clinical trial evaluating RBM-007 Injectable Solution, Aflibercept, and 1 other intervention for Exudative Age-related Macular Degeneration. Completed, enrolled 94 participants across 8 sites.

Detailed Summary

This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExudative Age-related Macular Degeneration
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 16, 2019
Enrollment StartDec 2, 2019
Primary CompletionNov 19, 2021
Study CompletionDec 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.5 years ago

Interventions

RBM-007 Injectable Solutiondrug

RBM-007 Injectable Solution

Afliberceptdrug

EYLEA® (aflibercept) Injection, for Intravitreal Use

Shamdrug

Sham intravitreal injection