NCT06942520 Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
| NCT ID | NCT06942520 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sierra Eye Associates |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 18 participants in total. It began in 2025-03-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06942520 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 89 Years, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06942520 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06942520 currently recruiting?
Yes, NCT06942520 is actively recruiting participants. Contact the research team at jvannavong@sierraeyeassociates.com for enrollment information.
Where is the NCT06942520 trial being conducted?
This trial is being conducted at Reno, United States.
Who is sponsoring the NCT06942520 clinical trial?
NCT06942520 is sponsored by Sierra Eye Associates. The trial plans to enroll 18 participants.