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Monoclonal Antibodies
EXG102-031 for Wet Age-Related Macular Degeneration
Phase 1
Recruiting
Led By Arshad Khanani, MD
Research Sponsored by Exegenesis Bio
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 throughout 52 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a new drug is safe for people with wet AMD, to stop the abnormal blood vessel growth and leakage that can lead to severe vision loss.
Who is the study for?
This trial is for men and women over 50 with wet age-related macular degeneration (nAMD) who've had some response to previous treatments. They must have a certain level of vision clarity in the affected eye, which should be pseudophakic (after cataract surgery). Participants need to understand the study and consent to join. Those with severe scarring, recent eye surgeries, other major eye diseases, or untreated glaucoma can't join.
What is being tested?
EXG102-031 is being tested for safety in patients with nAMD. The drug aims to block abnormal blood vessel growth in the eye that causes vision loss by leaking fluid into the macula. This phase of testing will determine if it's safe before checking its effectiveness on improving vision.
What are the potential side effects?
Since EXG102-031 is early in testing, specific side effects aren't listed yet. Generally, such drugs may cause irritation at injection site, inflammation inside the eye, increased intraocular pressure or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluation of safety and tolerability
Secondary study objectives
Evaluation of potential efficacy
Evaluation of potential safety
Evaluation of supplementary therapy injections received
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EXG102-031Experimental Treatment1 Intervention
Each participant will receive a single subretinal injection of EXG102-031 in the study eye. Participants will be enrolled into one of four dosage groups sequentially, and the dose administered will be determined based on which study group the participant is enrolled into.
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Who is running the clinical trial?
Exegenesis BioLead Sponsor
Arshad Khanani, MDPrincipal InvestigatorSierra Eye Associates
5 Previous Clinical Trials
1,068 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had eye surgery in the affected eye within the last 3 months.My eye has scarring or damage in the central vision area.I currently have an eye infection.My study eye has no other diseases affecting vision besides nAMD.I have a large bleed under the retina in the center of my vision.My glaucoma is advanced or not controlled in one eye.I am 50 years old or older.I have wet AMD with an active lesion in my eye being studied.I responded to anti-VEGF treatment during screening.I have never received gene therapy for my eyes or any part of my body.I have CNV or macular edema in my eye, but it's not due to AMD.I agree to participate in the trial and can sign the consent form.My study eye has a lens implant from cataract surgery.
Research Study Groups:
This trial has the following groups:- Group 1: EXG102-031
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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