Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

NCT ID: NCT03999801

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 865 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2028-12-31

Brief Summary

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period.

Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.

Conditions

Neovascular Age-related Macular Degeneration; Wet Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Main Observational Study

All subjects that previously received RGX-314 in a subretinal administration parent study are enrolled into this arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

RGX-314 Fellow Eye Treatment Substudy

RGX-314 Fellow Eye Treatment

Group Type: EXPERIMENTAL

RGX-314

Intervention Type: GENETIC

AAV8 vector containing a transgene for anti-VEGF Fab

Interventions

RGX-314

AAV8 vector containing a transgene for anti-VEGF Fab

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

1. Able and willing to provide written consent

2. Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314

Exclusions Criteria:

1. None

Fellow Eye Substudy:

1. Age ≤ 93 years

2. Currently or previously enrolled in the main observational study

3. Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration

4. Active nAMD in the fellow eye

5. BCVA between ≤ 80 and ≥ 20 letters in the fellow eye

Exclusion Criteria

1. CNV or macular edema in the fellow eye secondary to causes other than nAMD

2. Subfoveal fibrosis or atrophy in the fellow eye

3. Advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma

4. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months

5. History of intraocular surgery in the fellow eye within 12 weeks of screening

6. History of intravitreal therapy, such as intravitreal steroid injection or investigational product, other than an intravitreal therapy for nAMD, in the fellow eye within 6 months of screening

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Retinal Research Institute, LCC

Phoenix, Arizona, United States

California Retina Consultants CRC

Santa Barbara, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Sierra Eye Associates

Reno, Nevada, United States

University of Pennsylvania Department of Ophthalmology

Philadelphia, Pennsylvania, United States

MidAtlantic Retina

Philadelphia, Pennsylvania, United States

Charles Retina Institute

Germantown, Tennessee, United States

Retina Consultants of Texas Research Center

The Woodlands, Texas, United States

Countries

United States

Other Identifiers

RGX-314-5101

Identifier Type: -

Identifier Source: org_study_id