NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration (NCT05984927) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
United States, Canada20 participantsStarted 2023-09-08
Plain-language summary
This study will evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy administered by subretinal injections into a single selected eye as a single selected dose for patients with wet age-related macular degeneration (wAMD).
Who can participate
Age range50 Years ā 89 Years
SexALL
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Inclusion criteria
ā. Subjects ā„ 50 and ā¤ 89 years of age with a diagnosis of active subfoveal CNV secondary to wAMD in the Study Eye
ā. BCVA between 20/40 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD
ā. Administration of at least 3 anti-VEGF (vascular endothelial growth factor) injections in the study eye in the past 6 months for clinically active wAMD, the most recent of which was within 1 month prior to Screening Day -14 (Visit 1).
ā. Must be pseudo phakic (status post cataract surgery) in the Study Eye
ā. Female and Male reproductive status: Female subjects must be either: (1) of non-childbearing potential; or (2) of childbearing potential and using an acceptable method of birth control with a negative pregnancy test. Male subjects agree to refrain from sperm donations and practice contraception to avoid any pregnancy for 3 months after administration of NG101.
ā. Normal blood pressure (BP) and heart rate (HR), or near normal BP and HR not considered clinically significant (NCS) by the Investigator at the Screening Day -14 (Visit 1) and Day -7 (Visit 2)
ā. Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to the performance of any study-related procedures
ā. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations
Exclusion criteria
ā. CNV or macular edema in the Study Eye secondary to any causes other than AMD
What they're measuring
1
Adverse Events
Timeframe: From Day 0 (pre-treatment) through Week 24
. Any condition preventing visual acuity improvement in the Study Eye, e.g., fibrosis, atrophy, or retinal pigment epithelial tear involving the center of the macula
ā. Any ophthalmic condition that precludes adequate ophthalmic examination or requires treatment
ā. Retinal detachment or history of retinal detachment in the Study Eye
ā. Active uncontrolled glaucoma with intraocular pressure (IOP) ā„ 30 mmHg despite treatment with more than 2 glaucoma medications, advanced glaucoma with cup-to-disc ratio of ā„ 0.9, visual field defects secondary to glaucoma that involve the macula, and/or optic atrophy from glaucoma
ā. History of intravitreal therapy in the Study Eye, such as intravitreal steroid injection or an investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening
ā. History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye
ā. Photodynamic therapy or retinal laser for the treatment of wAMD within the last 6 months