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

Post-surgical Cystoid Macular Edema (PSCME) Clinical Trial

— TEMPEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769352
• Other study ID #: NA_00074523
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 14, 2013
• Last updated: August 19, 2016
• Start date: August 2012
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Post-surgical Cystoid Macular Edema (PSCME)

Intervention

Drug:
• PredA + Kelac
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.

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in BCVA		12 Weeks	No