Ozurdex Treatment for macular edema associated with retinitis pigmentosa
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0002497
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
Patients who are at least 18 years of age and had bilateral CME associated with RP are prospectively recruited. Diagnosis of RP was based on typical funduscopic finding of bilateral retinal degeneration, visual field constriction and/or ring scotoma, and markedly reduced rod response on standard electroretinography. To be included, RP patients are required to have macular cystic change as shown by spectral domain optical coherence tomography (OCT) with central subfield macular thickness (CSMT) of > 250 µm in both eyes.
Key exclusion criteria are as follows: (1) advanced RP with foveal atrophic change or visual acuity of hand motion or less; (2) aphakia or pseudophakic eyes with zonule dehiscence or defective posterior capsule; (3) history of glaucoma or IOP elevation in response to steroid treatment in either eye; (4) history of vitrectomy; (5) diabetic retinopathy in either eye; (6) any active intraocular or periocular infection in either eye; (7) history of intravitreal or periocular steroids within 12 months; (8) history of intraocular surgery within 6 months; (9) any uncontrolled systemic disease.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of CSMT
- Secondary Outcome Measures
Name Time Method BCVA change from baseline and the proportion of patients with CME improvement of CSMT decrease by = 25 % from baseline