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
Who is this study for? Patients with Macula Edema
What treatments are being studied? Episcleral Celecoxib
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Stanford Medicine Ophthalmology
Palo Alto
Time Frame
Start Date: 2021-03-05
Completion Date: 2024-06-30
Participants
Target number of participants: 3
Treatments
Experimental: Phase I open label study
Drug: Episcleral Celecoxib~Other Names:~* Sequestered, Transscleral, Controlled-Release Celecoxib~* Sustained Release Transscleral Celecoxib
Related Therapeutic Areas
Sponsors
Leads: Targeted Therapy Technologies, LLC