Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
preda + kelac Acular, Acuvail
At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.
(Active Comparator)
Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
preda + kelac Acular, Acuvail
At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.

Primary Outcomes

Measure
Mean change from baseline in BCVA
time frame: 12 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.