RECRUITING

Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Open Label, Controlled, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 AAV Gene Therapy Administered Via Subretinal Delivery in Participants With Center Involved Diabetic Macular Edema

Quick Facts

Study Start:2025-03-18

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06942520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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

Inclusion Criteria

Exclusion 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 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

Contacts and Locations

Study Contact

Clinical Research Study Coordinator

CONTACT

775-329-0286

jvannavong@sierraeyeassociates.com

Study Locations (Sites)

Sierra Eye Associates

Reno, Nevada, 89502

United States

Collaborators and Investigators

Sponsor: Sierra Eye Associates

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-03-18

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

diabetic macular edema
gene therapy

Additional Relevant MeSH Terms

Diabetic Macular Edema