NCT06942520RecruitingPhase 2
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 3 Dec 2024
- Start date
- 18 Mar 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Sierra Eye Associates
- Diseases
- Diabetic eye disease
- NCT number
- NCT06942520
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 18
- From 18 Mar 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Diabetic macular edema diagnosis ≥ 7 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 25 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.