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

Primary Purpose

Post-surgical Cystoid Macular Edema (PSCME)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PredA + Kelac
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-surgical Cystoid Macular Edema (PSCME) focused on measuring cystoid macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PredA q1h WA + Kelac qid

PredA qid + Kelac qid

Arm 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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Change in Central Subfield Thickness at Week 12 From Baseline
Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline
Mean Change in Intraocular Pressure at Week 12 From Baseline
Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
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.
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
Mean Change in Intraocular Pressure Between Week 12 and Week 24
Mean Change in Intraocular Pressure (IOP) between week 12 and week 24

Full Information

First Posted
January 14, 2013
Last Updated
August 18, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01769352
Brief Title
Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
Acronym
TEMPEST
Official Title
Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-surgical Cystoid Macular Edema (PSCME)
Keywords
cystoid macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PredA q1h WA + Kelac qid
Arm Type
Active Comparator
Arm 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)
Arm Title
PredA qid + Kelac qid
Arm Type
Active Comparator
Arm Description
Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
Intervention Type
Drug
Intervention Name(s)
PredA + Kelac
Other Intervention Name(s)
Acular, Acuvail, Pred Forte, Omnipred, Pred Mild
Intervention Description
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 Outcome Measure Information:
Title
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Mean Change in Central Subfield Thickness at Week 12 From Baseline
Description
Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline
Time Frame
Baseline and Week 12
Title
Mean Change in Intraocular Pressure at Week 12 From Baseline
Description
Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
Time Frame
Baseline and Week 12
Title
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
Description
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.
Time Frame
Week 12 and Week 48
Title
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
Description
Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48
Time Frame
Week 12 and Week 48
Title
Mean Change in Intraocular Pressure Between Week 12 and Week 24
Description
Mean Change in Intraocular Pressure (IOP) between week 12 and week 24
Time Frame
Week 12 and Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Campochiaro, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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