Eye drops to treat swelling related to eye inflammation
Phase 4
Recruiting
- Conditions
- Retinal disorders in diseases classified elsewhere,
- Registration Number
- CTRI/2018/05/013869
- Lead Sponsor
- Proctor Foundation
- Brief Summary
A study demonstrating that topical treatments are effective and safe would greatly impact practice patterns and treatment of macular edema secondary to uveitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- Key Inclusion criteria: 1.
- ≥18 years of age 2.
- Diagnosis of anterior, intermediate, posterior, or panuveitis (can be infectious or non-infectious) 3.
- Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature 4.
- If on oral corticosteroids, a stable dose of <10 mg prednisone/day for >4 weeks 5.
- If on systemic corticosteroid-sparing immunomodulatory therapy, a stable dose for >4 weeks 6.
- If using prednisolone acetate 1% drops, stable regimen of ≤2 drops per day for >4 weeks 7.
- If infectious uveitis, inflammation must be inactive or minimally active per definition above and on stable dose of treatment for ≥4 weeks with no anticipated changes to treatment during the trial Eye-level Inclusion Criteria: 1.
- ME defined as thickening of the 1mm central subfield of the macula greater than 2 standard deviations above normal thickness (>320 µm by Heidelberg spectral-domain OCT) 2.
- Baseline intraocular pressure >5 mmHg and <21 mmHg 3.
- Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography 4.
- Best-corrected visual acuity of 5/200 or better.
Exclusion Criteria
- Key Exclusion Criteria: 1.
- Use of oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline 2.
- Known allergy or hypersensitivity to any component of the study drugs 3.
- History of central serous chorioretinopathy in either eye 4.
- Intravitreal or periocular corticosteroid injection in the past 8 weeks, dexamethasone implant in the past 12 months, or a fluocinolone acetonide implant in the past 3 years 5.
- Presence of an epiretinal membrane—noted clinically or by OCT—in the study eye, thought to be significant enough to preclude improvement of ME 6.
- Previous pars plana vitrectomy 7.
- History of severe glaucoma (C/D ratio > 0.9 or any notching of optic nerve to rim) 8.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Central Subfield Thickness on OCT 4 weeks
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients achieving resolution, improvement, and recurrence of Macular edema by the Week 4 visit and by the Week 24 visit 2. BCVA at week 4
Trial Locations
- Locations (2)
Aravind Eye Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Aravind Eye Hospital and PG Institute of Ophthalmology
🇮🇳Madurai, TAMIL NADU, India
Aravind Eye Hospital🇮🇳Coimbatore, TAMIL NADU, IndiaDr S Bala MuruganPrincipal investigator914132619100drbalamuruganms@gmail.comDr VK AnuradhaPrincipal investigator914224360400anuradhadr@aravind.org