RGX-314 for Diabetic Macular Edema

(ELAAVATE Trial)

Overseen By Clinical Research Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sierra Eye Associates

Must be taking: Aflibercept

Must not be taking: Intravitreal steroids

Disqualifiers: Women of childbearing potential, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have had certain eye treatments recently, like intravitreal steroid injections, you may not be eligible to participate.

What is the purpose of this trial?

Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)

Eligibility Criteria

This trial is for adults with a condition called Center Involved - Diabetic Macular Edema (CI-DME), which affects the retina in people with diabetes. Specific eligibility criteria are not provided, but typically participants should have CI-DME and meet certain health standards.

Inclusion Criteria

HbA1c ≤12%

Provide written informed consent

BCVA in study eye 78 to 25 ETDRS letters (~20/32 to 20/320) at screening

Exclusion Criteria

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

My study eye does not have any conditions needing surgery soon or that could worsen my vision during the study.

Presence of an implant in the study eye at screening (excluding intraocular lens)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RGX-314 gene therapy or Aflibercept treatment for diabetic macular edema

52 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RGX-314

Trial Overview The study is testing two different doses of an experimental treatment called RGX-314 against a standard treatment, Aflibercept (2.0 mg). It's a phase 2 trial where patients are openly assigned to one of the treatments to compare effectiveness and safety.

Participant Groups

Group I: Treatment Arm (Dose 2) Experimental Treatment 1 Intervention

Genetic: RGX-314 Dose 2 -AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

Group II: RGX-314 Treatment Arm (Dose 1) Experimental Treatment 1 Intervention

Genetic: RGX-314 Dose 1 - AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

Group III: Aflibercept Treatment Arm Active Control 1 Intervention

Biological: Aflibercept IVT * Commercially available Active Comparator * Other Names: Eylea

Who Is Running the Clinical Trial?

Sierra Eye Associates

Lead Sponsor

REGENXBIO Inc.

Industry Sponsor

Trials

25

Recruited

3,100+