Status:
RECRUITING
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Lead Sponsor:
Elisigen, Inc.
Collaborating Sponsors:
ORA, Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50-89 years
Phase:
PHASE1
PHASE2
Brief 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 pat...
Detailed Description
This is a Phase 1/2a, multicenter, open-label, dose escalation study to evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy, administered by subretinal injection in p...
Eligibility Criteria
Inclusion
- Subjects ≥ 50 and ≤ 89 years of age with a diagnosis of active subfoveal CNV secondary to wAMD in the Study Eye
- BCVA between 20/40 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD
- 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).
- Must be pseudo phakic (status post cataract surgery) in the Study Eye
- 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.
- 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)
- 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
- Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations
Exclusion
- CNV or macular edema in the Study Eye secondary to any causes other than AMD
- 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
- Any ophthalmic condition that precludes adequate ophthalmic examination or requires treatment
- Retinal detachment or history of retinal detachment in the Study Eye
- Active uncontrolled glaucoma with intraocular pressure (IOP) ≥ 30 mmHg despite treatment with more than 2 glaucoma medications, advanced glaucoma with cup-to-disc ratio of ≥ 0.9, visual field defects secondary to glaucoma that involve the macula, and/or optic atrophy from glaucoma
- 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
- History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye
- Photodynamic therapy or retinal laser for the treatment of wAMD within the last 6 months
- Any prior therapeutic radiation in the region of the Study Eye such as whole brain radiation, proton beam radiation, gamma knife treatment, or plaque brachytherapy
- Any previous intraocular or refractive surgery on the Study Eye within 6 months
- Any previous gene therapy in the Study Eye
- Presence of an ocular implant in the Study Eye at Screening, excluding intraocular lens and custom flex iris prosthesis
- Any diabetic retinopathy or other retinal vascular disease including retinal vein occlusion, retinal artery occlusion, retinal arterial macro aneurysm, ocular ischemic syndrome, retinal vasculitis, vitritis, posterior uveitis
- Medically uncontrolled diabetes, defined as HbA1C \> 8.0
- History of ocular melanoma
- History of any known inherited retinal disease
- Currently taking any anticoagulant therapy, which is deemed medically necessary and cannot be permanently stopped at least 2 weeks prior to NG101 injection, excluding prophylactic low-dose aspirin therapy
- Any underlying systemic diseases as unstable or severe cardiovascular, cerebrovascular, dementia or neurodegenerative diseases of a level that prevents adequate evaluation of the subject during the study, active malignancy or currently undergoing treatment for active malignancy at Screening or a history of malignancy that precludes completion of this 260 week study, and immunocompromised conditions and/or need for immunosuppressive therapy
- Active hepatitis B or C
- History of human immunodeficiency virus (HIV), active tuberculosis, and/or syphilis
- Any significant illness that would preclude study compliance and follow-up
- Subjects who, in the Investigator's opinion, lack the mental capacity to provide written informed consent for study participation
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05984927
Start Date
September 8 2023
End Date
January 1 2030
Last Update
October 30 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
2
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
3
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada, V5Z 3N9
4
Sunnybrook Ophthalmology and Vision Services
Toronto, Ontario, Canada, M4N 3M5