Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
NCT ID: NCT06942520
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
18 participants
INTERVENTIONAL
2025-03-18
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RGX-314 Treatment Arm (Dose 1)
Genetic: RGX-314 Dose 1
\- AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
RGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
Treatment Arm (Dose 2)
Genetic: RGX-314 Dose 2
-AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
RGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
Aflibercept Treatment Arm
Biological: Aflibercept IVT
* Commercially available Active Comparator
* Other Names: Eylea
Aflibercept (2.0 mg)
Commercially available Active Comparator
Interventions
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RGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
RGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
Aflibercept (2.0 mg)
Commercially available Active Comparator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
89 Years
ALL
No
Sponsors
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REGENXBIO Inc.
INDUSTRY
Sierra Eye Associates
OTHER
Responsible Party
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Locations
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Sierra Eye Associates
Reno, Nevada, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SEA1979
Identifier Type: -
Identifier Source: org_study_id
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