Tests RGX-314 gene therapy against aflibercept in adults with diabetic macular edema
Compares RGX-314 gene therapy and aflibercept in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
Key facts
- Where
- Reno, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 89 years old?
Source: NCT06942520, who can take part
Where in United States
- Sierra Eye AssociatesReno, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sierra Eye Associates
- Trial code
- NCT06942520
- Record updated
- 24 April 2025
- Original description
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)Read full original descriptionShow less
A Randomized, Open Label, Controlled, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 AAV Gene Therapy Administered Via Subretinal Delivery in Participants With Center Involved Diabetic Macular Edema
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
Inclusion: 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: 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 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; 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; History of pan retinal photocoagulation in the study eye; 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; History of chronic renal failure requiring dialysis or kidney transplant; Diabetic macular edema diagnosis ≥ 7 years; 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.