Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
Trial ID or NCT#
NCT04120636
Status
NOT RECRUITING
Purpose
This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.
Official Title
Phase I Study of Sequestered Transscleral, Controlled-Release Celecoxib Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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.
Investigator(s)
Theodore Leng, MD, FACS
Ophthalmologist
Professor of Ophthalmology (Ophthalmology Research/Clinical Trials) and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (MSD)
Contact us to find out if this trial is right for you.
Contact
Amy Dennis, RN
650-497-7935
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