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

Neovascular Age-related Macular Degeneration Clinical Trial

— RGX-314 SRLTFU  

Official title:

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants With Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03999801
• Other study ID #: RGX-314-5101
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 31, 2019
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 865
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Main Observational Study:

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: Inclusion Criteria

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Genetic:
• RGX-314
AAV8 vector containing a transgene for anti-VEGF Fab

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Charles Retina Institute	Germantown	Tennessee
United States	MidAtlantic Retina	Philadelphia	Pennsylvania
United States	University of Pennsylvania Department of Ophthalmology	Philadelphia	Pennsylvania
United States	Retinal Research Institute, LCC	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	California Retina Consultants CRC	Santa Barbara	California
United States	Retina Consultants of Texas Research Center	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ocular adverse events and any serious adverse events in the study eye		5 years inclusive of parent study
Primary	Fellow eye substudy: Incidence of ocular adverse events and any serious adverse events in the fellow eye		54 weeks
Secondary	Change from baseline in best corrected visual acuity (BCVA) in the study eye	Mean change and proportion of participants losing greater than or equal to 5, 10, and 15 letters	5 years inclusive of parent study
Secondary	Change from baseline in Central Retinal Thickness (CRT) in the study eye	Mean change from baseline in CRT as measured by spectral domain optical coherence tomography (SD-OCT)	5 years inclusive of parent study
Secondary	Number of supplemental anti-VEGF injections in the study eye	Mean number of supplemental anti-VEGF injections based on chart review	5 years inclusive of parent study
Secondary	Number of retinal specialist visits for the study eye	Mean number of retinal specialist visits attended for nAMD based on chart review	5 years inclusive of parent study
Secondary	Fellow eye substudy: Change from baseline in best corrected visual acuity	Mean change from baseline in BCVA in the fellow eye	54 weeks
Secondary	Fellow eye substudy: Change from baseline in Central Retinal Thickness in the fellow eye	Mean change from baseline in CRT in the fellow eye as measured by SD-OCT	54 weeks
Secondary	Fellow eye substudy: Number of supplemental anti-VEGF injections in the fellow eye	Mean number of supplemental anti-VEGF injections in the fellow eye	54 weeks
Secondary	Fellow eye substudy: Aqueous and Serum RGX-314 transgene product (TP) concentrations in the fellow eye	Fellow eye aqueous and serum RGX-314 TP concentrations at assessed time points	54 weeks
Secondary	Fellow eye substudy: Immunogenicity measurements in the fellow eye	Fellow eye immunogenicity measurements at assessed timepoints	54 weeks