Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy

• Sponsor: REGENXBIO, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05296447
• Collaborator: (none)
• Enrollment: 60
• Locations: 18
• Anticipated Duration (Months): 69.9
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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 of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy, DR	Other: No Intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema
• Actual Study Start Date: Apr 4, 2022
• Anticipated Primary Completion Date: Feb 1, 2028
• Anticipated Study Completion Date: Feb 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Roll Over No intervention - all subjects that previously received RGX-314 in a parent study	Other: No Intervention; All subjects that previously received RGX-314 in a parent study

Outcome Measures

Primary Outcome Measures

1. To evaluate the long-term safety of RGX-314 [5 years inclusive of the parent study]

   Incidence of overall and ocular adverse events, serious adverse events, and all adverse events of special interest

Secondary Outcome Measures

1. Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in DR by ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography [5 years, inclusive of the parent study]

2. Proportion of participants achieving 0-step (no change), a 1-step or greater, a 2-step or greater, or a 3-step or greater improvement in DR per ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography from baseline [5 years, inclusive to the parent study]

3. Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA [5 years, inclusive to the parent study]

4. Proportion of participants gaining or losing ≥5, 10 and 15 letters in BCVA compared with baseline (ie, prior to RGX-314 administration in the parent study) [5 years, inclusive to the parent study]

5. Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT [5 years, inclusive to the parent study]

6. Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA [5 years, inclusive to the parent study]

7. Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP) [5 years, inclusive to the parent study]

8. Proportion of participants with any sight-threatening ocular diabetic complications [5 years, inclusive to the parent study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must provide written, signed informed consent for this study

• Must have been enrolled in a previous clinical study of RGX-314 for the treatment of DR without CI-DME and must have received an SCS injection of RGX-314 in that study

• Must be willing and able to comply with all study procedures

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Site Location	Phoenix	Arizona	United States	85014
2	Bakersfield Location	Bakersfield	California	United States	93311
3	Campbell Location	Campbell	California	United States	95008
4	Mountain View Location	Mountain View	California	United States	94040
5	Poway Location	Poway	California	United States	92064
6	Santa Barbara Location	Santa Barbara	California	United States	93103
7	Augusta Location	Augusta	Georgia	United States	30909
8	Oak Forest Location	Oak Forest	Illinois	United States	60452
9	Hagerstown Location	Hagerstown	Maryland	United States	21740
10	Boston Site Location	Boston	Massachusetts	United States	02114
11	Reno Location	Reno	Nevada	United States	89502
12	Teaneck Location	Teaneck	New Jersey	United States	07666
13	Albuquerque Location	Albuquerque	New Mexico	United States	87109
14	Durham Location	Durham	North Carolina	United States	27705
15	Pennsylvania Site Location	Philadelphia	Pennsylvania	United States	19107
16	Germantown Location	Germantown	Tennessee	United States	38138
17	Austin Location	Austin	Texas	United States	78750
18	Woodlands Location	The Woodlands	Texas	United States	77384

Sponsors and Collaborators

• REGENXBIO, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: REGENXBIO, Inc.
• ClinicalTrials.gov Identifier: NCT05296447
• Other Study ID Numbers: RGX-314-5201
• First Posted: Mar 25, 2022
• Last Update Posted: May 4, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by REGENXBIO, Inc.: Diabetic Retinopathy, DR
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy

Study Results

No Results Posted as of May 4, 2022