Macular edema following BRVO
Conditions
Interventions
STTA will be given on the STTA group and follow-up will be observed
Follow- up group will be observed
Sponsors
Aichi Medicak University Department of Ophthalmology
MIYAKE Eye Hospital Kamiiida daiichi General hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Select those who satisfies all the following criteria. 1) Age is between 20 years old and 79 years old. 2) Those whose eye has been diagnosed as BRVO-ME within 6 months before visiting screening inspection. 3) Those who have not been treated by topical medical therapy for BRVO-ME 4) Case that visual acuity and lesion of target patient satisfy the following both items. a) Fractional eyesight is 0.5 or more. b) Lesion of retinal vein branch obstruction lie within 2 papilla area or the shape of lesion wraps from the ear side. 5) Those whose intraocular pressure of the target eye is 21 mmHg or less. 6) Those who can agree the consent of participation for this research by free will in writing
Exclusion criteria
Exclusion criteria: 1) The subject eye has retinal disease except BRVO. 2) Transparency of the subject eye is turbid. 3) Those who have active ocular infection or inactive toxoplasmosis. 4) Those who have glaucoma or ocular hypertension, or medical histories of them. 5) Those who have histories of herpetic infection in their subject eyes. 6) Those who have uncontrollable systemic disease. 7) Those who are systemic debility, or have severe heart disease, severe cerebral blood flow disorder or cirrhosis. 8) Serum creatinine is 2.0 mg/dL or more. 9) Those who have undergone vitreous surgery to the subject eye or who are expected to undergo vitreous surgery. 10) Those who have undertaken the following treatment within 24 weeks or who are expected to be undergone. Administration of corticosteroid to thesubject eye below the Tenon capsule or retro-bulbar. Intravitreal of drug to the subject eye. Administration of immunosuppressant drug, immunomodulatory drug, antimetabolites drug and/or alkylating agents. Hyperbaric oxygen therapy or stellate ganglion block. Hemodialysis or peritoneal dialysis. 11) Those who have received laser or intraocular surgery in the subject eye within 12 weeks or who are expected to undergo them. 12) Those who have received treatments which are corticosteroid, oral carbonic anhydrase inhibitor, warfarin, heparin, heparin analogue, selective thrombin inhibitor, direct thrombin inhibitors or(/and) FXa inhibitors within 4 weeks. Those who are expected to undergo these therapies. 13) Those who are planning of ophthalmic surgery during the observation period. 14) Those who have drug allergy to the drugs which are used in this study. 15) Those who cannot sufficient dilate pupil for inspection. 16) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Retinal thickness (CRT) for both groups at four weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Transition of CRT, area under the curve of CRT-monitoring period, logMAR visual acuity, metamorphopsia score, visual analog scale score about vision defect consciousness, and Kaplan-Meier curve based on the number of cases which meet withdrawal criteria and adverse event about VA or CRT. | — |
Countries
Japan
Contacts
Public ContactHasegawa Miyuki
Aichi Medical University Department of Ophthalmology
Outcome results
None listed