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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post-surgical Cystoid Macular Edema (PSCME)

Intervention / Treatment
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* Drug: PredA + Kelac


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PredA q1h WA + Kelac qid<br>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<br>* 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.<br>* Other names: Pred Forte, Omnipred, Pred Mild;|
| Active Comparator: PredA qid + Kelac qid<br>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<br>* 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.<br>* Other names: Pred Forte, Omnipred, Pred Mild;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystoid macular edema