None listed
Conditions
Interventions
Drug : In RP patients with bilateral CME, one eye is treated with DEX implant (Ozurdex
Allergan, Inc., Irvine, CA) implant at baseline, and the fellow eye is observed. At month 6, both eyes are eligible for DEX treatment when CME persisted.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of CSMT | — |
Secondary
| Measure | Time frame |
|---|---|
| BCVA change from baseline and the proportion of patients with CME improvement of CSMT decrease by = 25 % from baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactUn Chul Park
Seoul National University Hospital
Outcome results
None listed