Episcleral Celecoxib for Macular Edema

Recruiting in Palo Alto (17 mi)

Overseen byTheodore Leng, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Targeted Therapy Technologies, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a treatment called Episcleral Celecoxib, which is applied to the outer layer of the eye. It is aimed at patients with macular edema and other inflammatory eye conditions. The drug works by reducing swelling and preventing harmful blood vessel growth in the eye. The main goal is to see if the treatment is safe and if it can improve vision by reducing inflammation.

Eligibility Criteria

This trial is for adults over 18 with inflammatory eye conditions like macular edema, affecting the retina or vitreous. Participants must have certain levels of visual impairment but not so severe that they can't see at all. Pregnant women, those who can't follow the study plan or have other serious eye issues besides inflammation are excluded.

Inclusion Criteria

Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF)

Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320)

I am 18 years old or older.

+1 more

Exclusion Criteria

You are currently pregnant or breastfeeding.

I do not have eye conditions that could affect safety or treatment results.

I understand the consent form, can cooperate with tests, and can attend follow-up visits.

Participant Groups

The trial is testing Episcleral Celecoxib's safety and its ability to reduce swelling and prevent abnormal blood vessel growth in the eye. It's an early-stage (Phase I) study focusing on patients with various retinal diseases and swelling behind the eye.

1Treatment groups

Experimental Treatment

Group I: Phase I open label studyExperimental Treatment1 Intervention

Drug: Episcleral Celecoxib Other Names: * Sequestered, Transscleral, Controlled-Release Celecoxib * Sustained Release Transscleral Celecoxib