Phase
Condition
Aging
Geographic Atrophy
Macular Degeneration
Treatment
NG101 AAV gene therapy
Clinical Study ID
Ages 50-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects ≥ 50 and ≤ 89 years of age with a diagnosis of active subfoveal CNVsecondary to wAMD in the Study Eye
BCVA between 20/40 and 20/400 in the Study Eye, with BCVA decrement primarilyattributable 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, themost 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) ofnon-childbearing potential; or (2) of childbearing potential and using an acceptablemethod of birth control with a negative pregnancy test. Male subjects agree torefrain from sperm donations and practice contraception to avoid any pregnancy for 3months after administration of NG101.
Normal blood pressure (BP) and heart rate (HR), or near normal BP and HR notconsidered 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 thestudy has been explained and prior to the performance of any study-relatedprocedures
Willingness and ability to comply with schedule for follow-up visits andpostoperative evaluations
Exclusion
Exclusion Criteria:
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 requirestreatment
Retinal detachment or history of retinal detachment in the Study Eye
Active uncontrolled glaucoma with intraocular pressure (IOP) ≥ 30 mmHg despitetreatment with more than 2 glaucoma medications, advanced glaucoma with cup-to-discratio 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 steroidinjection or an investigational product, other than anti-VEGF therapy, in the 6months prior to Screening
History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimallyinvasive glaucoma surgery (MIGS) device, or other filtration surgery in the StudyEye
Photodynamic therapy or retinal laser for the treatment of wAMD within the last 6months
Any prior therapeutic radiation in the region of the Study Eye such as whole brainradiation, 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 intraocularlens and custom flex iris prosthesis
Any diabetic retinopathy or other retinal vascular disease including retinal veinocclusion, retinal artery occlusion, retinal arterial macro aneurysm, ocularischemic 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 andcannot be permanently stopped at least 2 weeks prior to NG101 injection, excludingprophylactic low-dose aspirin therapy
Any underlying systemic diseases as unstable or severe cardiovascular,cerebrovascular, dementia or neurodegenerative diseases of a level that preventsadequate evaluation of the subject during the study, active malignancy or currentlyundergoing treatment for active malignancy at Screening or a history of malignancythat precludes completion of this 260 week study, and immunocompromised conditionsand/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 providewritten informed consent for study participation
Study Design
Study Description
Connect with a study center
Vancouver Coastal Health Research Institute
Vancouver, British Columbia V5Z 3N9
CanadaSite Not Available
Vancouver Coastal Health Research Institute
Vancouver 6173331, British Columbia 5909050 V5Z 3N9
CanadaSite Not Available
Sunnybrook Ophthalmology and Vision Services
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Vitreous Retina Macula Specialists of Toronto
Toronto, Ontario M8X 2X3
CanadaActive - Recruiting
Sunnybrook Ophthalmology and Vision Services
Toronto 6167865, Ontario 6093943 M4N 3M5
CanadaSite Not Available
Vitreous Retina Macula Specialists of Toronto
Toronto 6167865, Ontario 6093943 M8X 2X3
CanadaSite Not Available
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United StatesSite Not Available
Cincinnati Eye Institute
Cincinnati 4508722, Ohio 5165418 45242
United StatesSite Not Available
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Retina Consultants of Texas
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.