MedTrace Logo

A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

NCT04200248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-06-08

Study results available
· View outcomes & findings →

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).

Conditions

  • Exudative Age-related Macular Degeneration

Interventions

DRUG

RBM-007 Injectable Solution

RBM-007 Injectable Solution

DRUG

Aflibercept

EYLEA® (aflibercept) Injection, for Intravitreal Use

DRUG

Sham

Sham intravitreal injection

Sponsors & Collaborators

  • Ribomic USA Inc

    lead INDUSTRY

Principal Investigators

  • Padma Bezwada, Ph.D. · RIBOMIC USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-11-19
Completion
2021-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200248 on ClinicalTrials.gov