Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

Part of paid clinical trials in Reno, Nevada.

Sponsor
Sierra Eye Associates
Study ID
NCT06942520
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • RGX-314 Dose 1 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
  • RGX-314 Dose 2 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
  • Aflibercept (2.0 mg) — BIOLOGICAL
    Commercially available Active Comparator

Study Details

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

Key Dates

Start date
Mar 18, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sierra Eye AssociatesRenoNevada89502
Clinical Research Study Coordinator
[email protected]
775-329-0286
Arshad M Khanani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Reno, NV

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Sierra Eye Associates· Reno, NV

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