Recruiting
Phase 2

RGX-314

Sponsor:

Sierra Eye Associates

Code:

NCT06942520

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

RGX-314 Dose 1

RGX-314 Dose 2

Aflibercept (2.0 mg)

Study Details

Brief summary:

Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)

Conditions

Diabetic Macular Edema

Study ID

NCT06942520

Start date

Mar 18, 2025

Status verified date

Apr, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment
  • HbA1c ≤12%
  • BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening
  • Decreased visual acuity attributable primarily due to CI - DME
  • Demonstrate clinical response to aflibercept injection in the study eye
  • Provide written informed consent

Exclusion Criteria:

  • Women of childbearing potential
  • Neovascularization in the study eye from a cause other than DR
  • Evidence in the study eye of optic nerve pallor on clinical examination
  • History of pan retinal photocoagulation in the study eye
  • Any concurrent ocular condition in the study eye other than CI-DME that could require surgical intervention within 6 months or any condition in the study eye that may increase the risk to the participant, require either medical or surgical intervention during the study to prevent or treat vision loss, or interfere with the study procedures or assessments
  • Presence of an implant in the study eye at screening (excluding intraocular lens)
  • Any condition in the investigator's opinion that could limit VA improvement in the study eye
  • Active or history of glaucoma, steroid response, or ocular hypertension
  • Any prior intravitreal steroid injection in the study eye within 6 months prior to screening, administration in the study eye of Ozudrex® within 12 months prior to screening, or administration in the study eye if Iluven® within 36 months prior to screening
  • Diabetic macular edema diagnosis ≥ 7 years
  • History of chronic renal failure requiring dialysis or kidney transplant
  • Participation in any other gene therapy study or receipt of any investigational product within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is longer, or any plans to use an investigational product within 6 months following enrollment

Note: Other inclusion/exclusion criteria apply

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RGX-314 Treatment Arm (Dose 1)

Genetic: RGX-314 Dose 1

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

experimental: Treatment Arm (Dose 2)

Genetic: RGX-314 Dose 2

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

active comparator: Aflibercept Treatment Arm

Biological: Aflibercept IVT

  • Commercially available Active Comparator
  • Other Names: Eylea

Interventions

RGX-314 Dose 1

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

RGX-314 Dose 2

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

Aflibercept (2.0 mg)

Commercially available Active Comparator

Primary outcome measure

  • Mean change from baseline in BCVA in the study eye at Week 52 [ Time Frame: 52 Weeks ]

Central Contacts and Locations

Central contacts

Clinical Research Study Coordinator

775-329-0286jvannavong@sierraeyeassociates.com

Locations

Sierra Eye Associates

Recruiting

Reno, Nevada, United States, 89502

Contacts

Clinical Research Study Coordinator

775-329-0286jvannavong@sierraeyeassociates.com

Principal Investigator:

Arshad M Khanani, MD

More Information

Sponsor

Sierra Eye Associates

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Keywords

  • diabetic macular edema
  • gene therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sierra Eye Associates on 2025-04-24.