Clinical trial NCT01769352: Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
Official title: Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Post-surgical Cystoid Macular Edema (PSCME)
Keywords: cystoid macular edema
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Mean Change in Central Subfield Thickness at Week 12 From Baseline
timeFrame: Baseline and Week 12
measure: Mean Change in Intraocular Pressure at Week 12 From Baseline
timeFrame: Baseline and Week 12
measure: Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
timeFrame: Week 12 and Week 48
measure: Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
timeFrame: Week 12 and Week 48
measure: Mean Change in Intraocular Pressure Between Week 12 and Week 24
timeFrame: Week 12 and Week 48
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter A Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References: