RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

November 20, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Diabetic Retinopathy (DR)Center-Involved Diabetic Macular Edema (CI-DME)
Interventions
GENETIC

ABBV-RGX-314 Dose 1

AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

GENETIC

ABBV-RGX-314 Dose 2

AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

GENETIC

ABBV-RGX-314 Dose 3

AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)

DRUG

Topical Steroid

Topical Steroid

GENETIC

ABBV-RGX-314 Dose 4

AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)

BIOLOGICAL

Aflibercept

Aflibercept

Trial Locations (25)

19107

Mid Atlantic Retina, Philadelphia

21287

Wilmer Eye Institute/Johns Hopkins University School of Medicine, Baltimore

21740

Cumberland Valley Retina Consultants, Hagerstown

27705

Duke University Eye Center, Durham

30909

Southeast Retina Center, PC, Augusta

38138

Charles Retina Institute, P.C., Germantown

60452

University Retina and Macula Associates, PC, Oak Forest

62702

Springfield Clinic, Springfield

76028

Star Retina, Burleson

77384

Retinal Consultants of Texas, The Woodlands

78750

Austin Clinical Research, LLC, Austin

79606

Retina Research Institute of Texas, LLC, Abilene

85014

Retinal Research Institute, LLC, Phoenix

85016

Barnet Dulaney Perkins Eye Center, Phoenix

87109

Vision Research Center Eye Associates of New Mexico, Albuquerque

89502

Sierra Eye Associates, Reno

90017

Retina-Vitreous Associates Medical Group, Beverly Hills

91107

California Eye Specialists Medical Group, Inc, Pasadena

92064

Retinal Consultants San Diego, Poway

93103

California Retina Consultants, Santa Barbara

93309

California Retina Consultants, Bakersfield

94040

Northern California Retina Vitreous Associates Medical Group, Inc., Mountain View

95008

Retinal Diagnostic Center, Campbell

02114

Ophthalmic Consultants of Boston, Boston

07666

NJ Retina, Teaneck

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

REGENXBIO Inc.

INDUSTRY

lead

AbbVie

INDUSTRY