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Anti-VEGF Therapy
Axitinib Implant for Age-Related Macular Degeneration
Phase 3
Recruiting
Led By Dilsher Dhoot, MD
Research Sponsored by Ocular Therapeutix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatment naïve juxtafoveal and/or subfoveal neovascularization secondary to Neovascular Age-Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new treatment called Intravitreal OTX-TKI (Axitinib Implant) for people with a specific eye condition called Neovascular Age-Related Macular Deg
Who is the study for?
This trial is for individuals who have been diagnosed with Neovascular Age-Related Macular Degeneration (nAMD) within the last 3 months. They should have received up to two aflibercept injections recently and must not have significant scarring or vision loss in their other eye.
What is being tested?
The study tests the effectiveness and safety of an Axitinib implant (OTX-TKI) compared to standard treatment with aflibercept injections in patients suffering from nAMD.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, changes in vision, increased eye pressure, bleeding inside the eye, and possible infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any treatment for my wet AMD affecting the center of my vision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best Corrected Visual Acuity (BCVA)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: OTX-TKI Re-doseExperimental Treatment1 Intervention
Group II: Aflibercept 8mg high doseExperimental Treatment1 Intervention
Group III: Aflibercept 2mg on labelActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTX-TKI
2019
Completed Phase 1
~30
Aflibercept
2016
Completed Phase 4
~2550
Find a Location
Who is running the clinical trial?
FortreaIndustry Sponsor
20 Previous Clinical Trials
4,806 Total Patients Enrolled
1 Trials studying Macular Degeneration
300 Patients Enrolled for Macular Degeneration
Ocular Therapeutix, Inc.Lead Sponsor
54 Previous Clinical Trials
5,577 Total Patients Enrolled
4 Trials studying Macular Degeneration
360 Patients Enrolled for Macular Degeneration
Duke UniversityOTHER
2,462 Previous Clinical Trials
2,968,095 Total Patients Enrolled
14 Trials studying Macular Degeneration
1,927 Patients Enrolled for Macular Degeneration
Dilsher Dhoot, MDPrincipal InvestigatorCalifornia Retina Consultants (CRC) - Santa Barbara
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Macular Degeneration
300 Patients Enrolled for Macular Degeneration