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OCU-10-C-110 Injection for Age-Related Macular Degeneration
Phase 1
Recruiting
Research Sponsored by Ocugenix Corporation
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 cohort a - 8 weeks; cohort b - 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug to treat AMD. It looks at safety of the drug in single and repeat doses.
Who is the study for?
This trial is for adults with active wet age-related macular degeneration (nAMD), confirmed by recent tests. Participants must have had an approved anti-VEGF eye injection within 7 to 14 days before starting the study.
What is being tested?
The trial is testing OCU-10-C-110, a new medication given as an injection into the eye. It's conducted in multiple centers and involves initial single doses followed by repeated administration at the highest tolerated dose.
What are the potential side effects?
Potential side effects of OCU-10-C-110 are not detailed here but may include typical reactions related to eye injections such as discomfort, redness, or inflammation at the injection site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort a - 8 weeks; cohort b - 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort a - 8 weeks; cohort b - 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ocular safety - AE
Secondary study objectives
Systemic safety - AE
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort B - Dose TBDExperimental Treatment1 Intervention
Group II: Cohort A - Dose 3Experimental Treatment1 Intervention
Group III: Cohort A - Dose 2Experimental Treatment1 Intervention
Group IV: Cohort A - Dose 1Experimental Treatment1 Intervention
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Who is running the clinical trial?
Ocugenix CorporationLead Sponsor
Roger Goldberg, MDStudy DirectorLexitas Pharma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues that would make the study drug unsafe for me.I have a recent eye condition due to AMD causing abnormal blood vessels.I received an eye injection for VEGF treatment 7-14 days ago.I have had eye surgery or issues like retinal detachment in the eye being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A - Dose 1
- Group 2: Cohort A - Dose 2
- Group 3: Cohort A - Dose 3
- Group 4: Cohort B - Dose TBD
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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