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

Phase 2RecruitingNCT06942520

Sierra Eye Associates18 enrolled

Overview

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

This Phase 2 trial is an open label, randomized, active controlled, dose-ranging trial to allow for preliminary safety and efficacy data on subretinal (SR) delivery of RGX-314 in participants with CI - DME

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

RGX-314 Dose 1GENETIC

AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

RGX-314 Dose 2GENETIC

AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

Aflibercept (2.0 mg)BIOLOGICAL

Commercially available Active Comparator

Eligibility

Sex: ALLMin age: 25 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion 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 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

Locations (1)

Sierra Eye Associates

Reno, Nevada, United States

RECRUITING

Outcomes

Primary Outcomes

Mean change from baseline in BCVA in the study eye at Week 52

To evaluate the effect of RGX-314 on BCVA at Week 52

Time frame: 52 Weeks

Secondary Outcomes

Mean change from baseline in BCVA in the study eye over time

To evaluate the effect of RGX-314 on BCVA over time

Time frame: 52 Weeks

Proportion of participants with BCVA of 20/40 or better (ETDRS ≥ 69 letters) in the study eye over time

To evaluate the effect of RGX-314 on BCVA over time

Time frame: 52 Weeks

Mean change from baseline in central subfield thickness (CST) in the study at week 52

To evaluate the effect of RGX-314 on anatomic outcomes and CST (as determined by SD OCT measurement) at Week 52

Time frame: 52 Weeks

Mean change from baseline in CST in the study eye on SD-OCT at Week 26 and Week 52

To evaluate the effect of RGX-314 on anatomic outcomes and CST (as determined by SD OCT measurement) at Week 52

Time frame: 52 Weeks

Proportion of participants with an absence of CI-DME in the study eye at Week 26 and Week 52

To evaluate the effect of RGX-314 on anatomic outcomes and CST (as determined by SD OCT measurement) at Week 52

Time frame: 52 Weeks

Proportion of participants achieving a 2-step or greater improvement or any improvement (a 1-step or greater improvement) in DR in the study eye by ETDRS DRSS on 4 widefield digital stereoscopic fundus photography at Week 52

To evaluate the effect of RGX-314 on DR by the ETDRS DRSS at Week 52

Central Contacts

Clinical Research Study Coordinator

CONTACT

775-329-0286 jvannavong@sierraeyeassociates.com

Data from ClinicalTrials.gov

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