Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Post-surgical Cystoid Macular Edema (PSCME)

Treatments: Drug: PredA + Kelac

Study type: Interventional

Funder types: Other

Identifiers

NCT01769352

NA_00074523

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

PredA q1h WA + Kelac qid

Active Comparator group

Description:

Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)

Treatment:

Drug: PredA + Kelac

PredA qid + Kelac qid

Active Comparator group

Description:

Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)

Treatment:

Drug: PredA + Kelac