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New treatment option for Diabetic Macular Edema
Official title Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
ClinicalTrials.gov ID: NCT06942520
What this study is testing
What is RGX-314 Dose 1?
RGX-314 Dose 1 is an investigational medicine, being studied as a potential treatment for diabetic macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 89
You may be able to join if
- 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
You likely can't join if
- 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...
- Presence of an implant in the study eye at screening (excluding intraocular lens)
See the full eligibility 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Reno, Nevada, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reno, Nevada, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.