Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

• Status: Unknown status
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targeted Therapy Technologies, LLC
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Age >= 18 years;

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

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

• Inflammatory disorders of the sclera, choroid, retina or vitreous

Exclusion Criteria:

• Inability to understand informed consent, cooperate with testing or return to follow up visits;

• Pregnant or lactating women;

• Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.