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Tyrosine Kinase Inhibitor

OTX-TKI for Age-Related Macular Degeneration

Phase 1
Waitlist Available
Research Sponsored by Ocular Therapeutix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test a new medicine for age-related macular degeneration. Researchers will study how well the medicine works and if it is safe.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have received at least 3 anti-VEGF injections in the past year.
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BCVA ETDRS score between 24 and 83 letters (~20/25 to ~20/320 Snellen equivalent).
Select...
You have received an anti-VEGF injection within the past 4 weeks prior to screening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Absence of Fluid
BCVA changes
Central subfield thickness changes
+2 more

Trial Design

2Treatment groups
Active Control
Group I: OTX-TKIActive Control1 Intervention
Group II: AfliberceptActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Lead Sponsor
53 Previous Clinical Trials
5,556 Total Patients Enrolled

Frequently Asked Questions

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

How many healthcare facilities are participating in this research trial?

"This study is presently enrolling patients at 14 different sites, including Site 6 in Bakersfield, California; Site 3 in Altamonte Springs, Florida; and Site 5 in Oxnard, Texas."

Answered by AI

What medical conditions are Aflibercept treatments frequently employed to address?

"Aflibercept is a viable treatment option for patients suffering from the degenerative wet age-related macular edema, as well as those with diabetes induced macular swelling."

Answered by AI

What are the potential hazards associated with Aflibercept treatment?

"Due to its early-stage testing, aflibercept's safety has been given an assessment of 1 on our scale. This is because Phase I trials provide limited data regarding the efficacy and security of this medication."

Answered by AI

What is the prime aim of this research?

"According to the research institute, Ocular Therapeutix, Inc., primary outcomes measured over a course of 12 months will be changes in Best Corrected Visual Acuity (BCVA). Secondary results being evaluated include BCVA change from baseline, prevalence of foveal fluid absence and proportion of patients requiring rescue therapy."

Answered by AI

Are there any precedents of research that have utilized Aflibercept?

"The pharmaceutical aflibercept was initially trialed in 2014 at M.D Anderson Cancer Center, and there have been 231 trials conducted since then. As of now, 45 studies that are recruiting participants can be found primarily within Bakersfield, California."

Answered by AI

What is the enrollment cap for this clinical investigation?

"At present, this medical trial is not recruiting. It first appeared on July 28th 2021 and was recently updated on September 1st 2022. Nonetheless, there are 159 other experiments actively enrolling individuals with macular degeneration and 45 trials that accept Aflibercept patients."

Answered by AI

Is there currently a call for enrollment in this experiment?

"Unfortunately, this investigation is not accepting new participants at the present moment. The clinical trial was first listed on July 28th 2021 and last updated September 1st 2022. However, there are 159 trials for macular degeneration and 45 studies for Aflibercept that are actively searching for patients to join their program."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I wish to preserve existing vision.
PatientReceived no prior treatments
~6 spots leftby Mar 2025