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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769352
First Posted: January 16, 2013
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Post-surgical Cystoid Macular Edema (PSCME) Drug: PredA + Kelac Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline [ Time Frame: Baseline and Week 12 ]
    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 [ Time Frame: Baseline and Week 12 ]
    Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline

  • Mean Change in Intraocular Pressure at Week 12 From Baseline [ Time Frame: Baseline and Week 12 ]
    Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline

  • Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 12 and Week 48 ]
    Mean Change in Intraocular Pressure (IOP) between week 12 and week 24


Enrollment: 42
Study Start Date: August 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769352


Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01769352     History of Changes
Other Study ID Numbers: NA_00074523
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: April 17, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
cystoid macular edema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ophthalmic Solutions
Prednisolone acetate
Pharmaceutical Solutions
Anti-Inflammatory Agents