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Anti-VEGF Therapy

Control 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

Are at least older than 50 years of age at Day 1

Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 104 weeks

Awards & highlights

Study Summary

This trial is testing a new treatment called Intravitreal OTX-TKI for people with a specific eye condition called neovascular age-related macular degeneration. The trial aims to determine if this

Who is the study for?

This trial is for individuals over 50 years old with a new diagnosis of Neovascular Age-Related Macular Degeneration (nAMD) and have not been treated for it. They must have good vision in at least one eye, with a visual acuity score close to 20/20. People can't join if they only have one working eye or very poor vision in their other eye.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of an implant called OTX-TKI (axitinib implant), which is placed inside the eye, against Aflibercept, an existing treatment for nAMD. The goal is to see how well these treatments help maintain or improve vision.See study design

What are the potential side effects?

Possible side effects may include discomfort in the eye, increased pressure within the eyeball, bleeding, infection risk after the procedure, and potential inflammation or irritation from either treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 50 years old.

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My vision, with correction, is about 20/20.

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I have not received any treatments for wet AMD in either eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best corrected visual acuity (BCVA)

Other outcome measures

Incidence and severity of treatment emergent adverse events (AEs)

Trial Design

2Treatment groups

Experimental Treatment

Group I: OTX-TKI (axitinib implant)Experimental Treatment1 Intervention

Group II: ControlExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept

2016

Completed Phase 4

~2540

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

FortreaUNKNOWN

9 Previous Clinical Trials

2,120 Total Patients Enrolled

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,420,216 Total Patients Enrolled

Ocular Therapeutix, Inc.Lead Sponsor

53 Previous Clinical Trials

5,277 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still eligible to apply for participation in this ongoing trial?

"According to the latest information on clinicaltrials.gov, this particular trial is not currently in need of participants. The initial posting was made on January 29th, 2024, and the most recent update occurred on January 24th, 2024. However, it's worth noting that there are currently 171 other ongoing trials actively seeking patients at this time."

Answered by AI

Has the Food and Drug Administration granted its approval for OTX-TKI (axitinib implant) to be used in medical practice?

"Given that this is a Phase 3 trial, our team at Power rates the safety of OTX-TKI (axitinib implant) as 3 on a scale from 1 to 3. This rating indicates that there is existing data supporting both efficacy and multiple rounds of safety assessments for this treatment."

Answered by AI

Are there several medical facilities within the state conducting this clinical trial?

"This clinical trial is being conducted at several locations, including Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas) in Bellaire, Texas; Cumberland Valley Retina Consultants in Hagerstown, Maryland; and Retina Consultants of Houston in The Woodlands, Nevada. Additionally, there are five other sites where the study is also taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

2024. "Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06223958.