Episcleral Dexamethasone 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 phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.

Eligibility Criteria

This trial is for adults over 18 with Type I or II diabetes who have a specific level of vision impairment due to diabetic macular edema. They should have tried other treatments like laser or anti-VEGF therapy. People with a history of glaucoma or steroid-induced eye pressure issues can't join.

Inclusion Criteria

I am 18 years old or older.

Your vision in the study eye is between 20/32 and 20/320.

I have never had glaucoma or eye pressure issues from steroids.

+5 more

Participant Groups

The study tests the safety and effectiveness of Episcleral Dexamethasone, which is placed near the eye, in patients with stubborn swelling in the retina caused by diabetes (refractory diabetic macular edema).

1Treatment groups

Experimental Treatment

Group I: Phase 1Experimental Treatment1 Intervention

Phase I open label study