Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
This trial is active, not recruiting.
|Condition||post-surgical cystoid macular edema (pscme)|
|Treatment||preda + kelac|
|Phase||phase 2/phase 3|
|Sponsor||Johns Hopkins University|
|Start date||August 2012|
|End date||December 2016|
|Trial size||46 participants|
|Trial identifier||NCT01769352, NA_00074523|
The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Mean change from baseline in BCVA
time frame: 12 Weeks
Male or female participants at least 18 years old.
- Age more than or equal to 18 years
- Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
- BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
- In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.
- Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
- Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
- Pre-existing diagnosis of glaucoma in the study eye
- Inability to comply with study or follow up procedures
- Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).
|Official title||Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)|
|Principal investigator||Peter A Campochiaro, MD|
|Description||Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.|
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