RGX-314 Gene Therapy for Diabetic Retinopathy (ALTITUDE Trial)

Phase 2

Recruiting

Research Sponsored by REGENXBIO, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Presence of any active CI-DME

Any evidence or documented history of PRP or retinal laser in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new gene therapy treatment for diabetic retinopathy, a progressive complication of diabetes that is a leading cause of vision loss. The new treatment is being developed as a potential one-time treatment that may provide a longer duration of therapeutic effect and intervene at an earlier stage of the disease.

Who is the study for?

This trial is for adults aged 25-89 with diabetic retinopathy, who have good vision (20/40 or better) and can delay other treatments like PRP or anti-VEGF injections for at least 6 months. It's not for those with active macular edema, prior eye surgeries, potential pregnancy, or retinal issues not caused by diabetes.

What is being tested?

The study tests RGX-314 gene therapy as a one-time treatment for diabetic retinopathy. Participants will receive different doses of RGX-314 administered into the suprachoroidal space of the eye to see if it can improve their condition without frequent treatments.

What are the potential side effects?

Potential side effects may include discomfort in the eye where RGX-314 is injected, increased pressure inside the eye, inflammation, bleeding complications and possible impact on vision. A topical steroid might be used to manage some side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active diabetic macular edema.

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I have had PRP or retinal laser treatment in my study eye.

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My eye condition is not due to diabetic retinopathy.

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I have had or currently have a detached retina in one eye.

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I have had surgery to remove the vitreous gel from my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the effect of RGX-314 on DR by the Early Treatment Diabetic Retinopathy Study (ETDRS)-Diabetic Retinopathy Severity Scale (-DRSS) at week 48

Secondary study objectives

To assess the safety and tolerability of RGX-314

To evaluate the effect of RGX-314 on DR (ETDRS-DRSS) over time

To evaluate the incidences of ocular inflammation following SCS RGX-314 administration

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