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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01769352
First received: January 14, 2013
Last updated: February 17, 2016
Last verified: February 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 from baseline in BCVA [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: August 2012
Estimated Study Completion Date: September 2016
Primary Completion Date: August 2015 (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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01769352     History of Changes
Other Study ID Numbers: NA_00074523 
Study First Received: January 14, 2013
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 21, 2016