Clinical trial NCT04120636: Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Macula Edema
Radiation Retinopathy
Branch Retinal Vein Occlusion
Epiretinal Membrane
Central Serous Retinopathy With Pit of Optic Disc
Commotio Retinae
Vitritis
Keywords: Macula Edema
Radiation Retinopathy
Branch Retinal Vein Occlusion
Epiretinal Membrane
Central Serous Retinopathy with Pit of Optic Disc
Commotio Retinae
Vitritis
Lead sponsor: Targeted Therapy Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema \& inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT).

Eligibility 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.

Primary outcomes:
measure: The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
timeFrame: 12 Months
Secondary outcomes:
measure: A secondary outcome is assessment of visual acuity.
timeFrame: 12 Months
measure: A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
timeFrame: 12 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medicine Ophthalmology
state: California
Study officials:
affiliation: Stanford Medicine Ophthalmology [Recruiting]
name: Theodore Leng, MD
role: PRINCIPAL_INVESTIGATOR
References: