UnknownPhase 1

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

United States2 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.

Timeframe: 12 Months

Trial details

NCT IDNCT04120311

SponsorTargeted Therapy Technologies, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Macular Edema trials