NCT06942520 · Sierra Eye Associates
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
(ELAAVATE)
What this study is about
Phase 2 open label, randomly assigned, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
View original scientific description
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
Interventions
GENETIC
RGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
GENETIC
RGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
BIOLOGICAL
Aflibercept (2.0 mg)
Commercially available Active Comparator
Primary outcome measures
Mean change from baseline in BCVA in the study eye at Week 52
Time frame: 52 Weeks
To evaluate the effect of RGX-314 on BCVA at Week 52
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment
- 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
Where
- Reno, Nevada
Collaborators
REGENXBIO Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2025 · Source of record for eligibility and locations