Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

Trial ID or NCT#

NCT04120636

Status

recruiting iconRECRUITING

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: No
Inclusion Criteria:
  1. - 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:
  1. - 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
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)

Contact us to find out if this trial is right for you.

Contact

Amy Dennis, RN
650-497-7935