Clinical trial NCT04120311: Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
Official title: Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone 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: Macular Edema
Radiation Retinopathy
Branch Retinal Vein Occlusion
Epiretinal Membrane
Central Serous Retinopathy With Pit of Optic Disc
Commotio Retinae
Vitritis
Keywords: Macular 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: 2
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 anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.

Detailed description: 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. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. 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) and fluorescein angiogram.

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: A 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
name: Theodore Leng, MD
role: PRINCIPAL_INVESTIGATOR
References: