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AAVCAGsCD59 for the Treatment of Wet AMD

NCT03585556 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-30

No results posted yet for this study

Summary

Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central subfoveal thickness (CST) of \>50 micrometers on OCT from Day 0, new subretinal hemorrhage on clinical exam, and/or loss of 10 or more ETDRS letters from the previous month exam.

Conditions

Interventions

DRUG

Intravitreal anti-VEGF

Intravitreal injection of anti-VEGF at Day 0 then monthly as needed

BIOLOGICAL

Intravitreal AAVCAGsCD59

An intravitreal injection of AAVCAGsCD59 will occur at Day 7 once

DRUG

Oral prednisolone

A 7 day tapering dose of oral prednisone will be taken at Day 30 by all patients

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2020-01-29
Completion
2022-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03585556 on ClinicalTrials.gov