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Gene Therapy
NG101 Gene Therapy for Age-Related Macular Degeneration
Phase 1 & 2
Recruiting
Led By Christopher D Riemann, MD
Research Sponsored by Neuracle Genetics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day -7 to weeks 24, 52, 104, 156, 208 and 260
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if gene therapy can safely and effectively treat wet age-related macular degeneration.
Who is the study for?
This trial is for individuals aged 50 to 89 with wet age-related macular degeneration (wAMD) in one eye, who have had at least three anti-VEGF injections in the past six months. Participants must have undergone cataract surgery and not be pregnant or able to become pregnant without contraception. They should not have any severe systemic diseases, uncontrolled glaucoma, recent ocular surgeries, other retinal diseases, or be on certain anticoagulants.
What is being tested?
The study tests NG101 AAV gene therapy given as a single dose through subretinal injection into one eye of patients with wAMD. It aims to assess the treatment's safety and initial effectiveness in improving vision affected by this condition.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical reactions related to subretinal injections such as discomfort at the injection site, increased intraocular pressure, inflammation inside the eye, bleeding or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day -7 to weeks 24, 52, 104, 156, 208 and 260
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day -7 to weeks 24, 52, 104, 156, 208 and 260
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Secondary study objectives
Best Corrected Visual Acuity (BCVA)
Central Subfield Thickness (CST)
Cumulative Number of Rescue Therapy Injections
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: NG101 Gene Therapy Group 3Experimental Treatment1 Intervention
Single subretinal injection of 8x10\^9 vector genomes of NG101 AAV gene therapy
Group II: NG101 Gene Therapy Group 2Experimental Treatment1 Intervention
Single subretinal injection of 3x10\^9 vector genomes of NG101 AAV gene therapy
Group III: NG101 Gene Therapy Group 1Experimental Treatment1 Intervention
Single subretinal injection of 1x10\^9 vector genomes of NG101 AAV gene therapy
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Who is running the clinical trial?
Neuracle Genetics, IncLead Sponsor
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,941 Total Patients Enrolled
Christopher D Riemann, MDPrincipal InvestigatorNeuracle Genetics, Inc. Medical Director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My vision in the study eye is between 20/63 and 20/400, mainly due to wet AMD.My study eye has had a retinal detachment.I have had eye melanoma in the past.My vision loss is not due to AMD but another cause.My eye condition cannot improve due to severe damage in the center of my retina.I have had gene therapy in my affected eye.I am able to understand and provide consent for my participation in the study.I do not have any diabetic eye diseases or other serious eye conditions.I've had 3 or more anti-VEGF injections in one eye within the last 6 months.I have a known genetic eye disease.I have an eye condition that needs treatment or prevents a full eye exam.I am using effective birth control or am not able to have children, and I have a negative pregnancy test.I am between 50 and 89 years old with a specific type of wet age-related macular degeneration.I have had cataract surgery in the eye being studied.I am willing and able to follow the schedule for all my follow-up visits and evaluations after surgery.I have severe glaucoma not controlled by medication.I have a history of HIV, active tuberculosis, or syphilis.I haven't had eye surgery in the last 6 months.I have had radiation treatment near my eye.I have had eye surgery for glaucoma or similar conditions.I am on necessary anticoagulant therapy that can't be stopped for the NG101 injection, except for low-dose aspirin.I have had photodynamic or laser therapy for wet AMD.I haven't had any eye injections except for anti-VEGF in the last 6 months.I do not have severe health issues that would interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: NG101 Gene Therapy Group 1
- Group 2: NG101 Gene Therapy Group 2
- Group 3: NG101 Gene Therapy Group 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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