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

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.

Study Overview

• Status: Completed
• Conditions: Post-surgical Cystoid Macular Edema (PSCME)
• Intervention / Treatment: Drug: PredA + Kelac

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Wilmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PredA q1h WA + Kelac qid; Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)	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.; Other Names: Acular, Acuvail; Pred Forte, Omnipred, Pred Mild
Active Comparator: PredA qid + Kelac qid; Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)	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.; Other Names: Acular, Acuvail; Pred Forte, Omnipred, Pred Mild

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline	Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Central Subfield Thickness at Week 12 From Baseline	Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline	Baseline and Week 12
Mean Change in Intraocular Pressure at Week 12 From Baseline	Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline	Baseline and Week 12
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48	Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.	Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48	Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48	Week 12 and Week 48
Mean Change in Intraocular Pressure Between Week 12 and Week 24	Mean Change in Intraocular Pressure (IOP) between week 12 and week 24	Week 12 and Week 48

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (Estimate): January 16, 2013

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: cystoid macular edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Anti-Inflammatory Agents; Prednisolone acetate
• Other Study ID Numbers: NA_00074523