Clinical trial NCT05296447: Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetic Retinopathy, DR
Keywords: Diabetic Retinopathy, DR
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes participants who received RGX-314 in a parent study of DR without center involved-diabetic macular edema

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the long-term safety of RGX-314
timeFrame: 5 years inclusive of the parent study
Secondary outcomes:
measure: 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
timeFrame: 5 years, inclusive of the parent study
measure: 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
timeFrame: 5 years, inclusive to the parent study
measure: Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA
timeFrame: 5 years, inclusive to the parent study
measure: 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)
timeFrame: 5 years, inclusive to the parent study
measure: Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT
timeFrame: 5 years, inclusive to the parent study
measure: 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
timeFrame: 5 years, inclusive to the parent study
measure: Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)
timeFrame: 5 years, inclusive to the parent study
measure: Proportion of participants with any sight-threatening ocular diabetic complications
timeFrame: 5 years, inclusive to the parent study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group Inc
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group, Inc
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants CRC
state: California
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Reno
country: United States
facility: Sierra eye Associates
state: Nevada
city: Teaneck
country: United States
facility: New Jersey Retina
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Retinovitreous Associates, LTD
state: Pennsylvania
city: Germantown
country: United States
facility: Charles Retina Institute, P.C
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
References: