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CompletedNCT01769352TEMPESTUpdated Sep 15, 2017Results posted

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

A Phase 2/3 interventional study of PredA + Kelac in Post-surgical Cystoid Macular Edema (PSCME), sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Johns Hopkins University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post-surgical Cystoid Macular Edema (PSCME)

Keywords

  • cystoid macular edema
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 42 is below the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugPredA + 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.

    Also known as: Acular, Acuvail, Pred Forte, Omnipred, Pred Mild

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Mean Change in Central Subfield Thickness at Week 12 From Baseline

    Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline

    Time frame: Baseline and Week 12

  2. Mean Change in Intraocular Pressure at Week 12 From Baseline

    Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline

    Time frame: Baseline and Week 12

  3. 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.

    Time frame: Week 12 and Week 48

  4. 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

    Time frame: Week 12 and Week 48

  5. Mean Change in Intraocular Pressure Between Week 12 and Week 24

    Mean Change in Intraocular Pressure (IOP) between week 12 and week 24

    Time frame: Week 12 and Week 48

07

Results

Posted Sep 15, 2017

Participant flow

Participant flow — Overall Study
MilestonePost-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2
Started131298
Completed131298
Not completed0000

Outcome measures

PrimaryMean 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · letters
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
lettersPost-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline10.6 ± 2.67.8 ± 3.413.1 ± 3.49.4 ± 3.6
SecondaryMean Change in Central Subfield Thickness at Week 12 From Baseline

Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline

Time frame:
Baseline and Week 12
Reported as:
Mean · µm
Mean Change in Central Subfield Thickness at Week 12 From Baseline
µmPost-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2
Mean Change in Central Subfield Thickness at Week 12 From Baseline-152.7 ± 33.5-56.4 ± 21.0-25.9 ± 25.7-75.0 ± 30.7
SecondaryMean Change in Intraocular Pressure at Week 12 From Baseline

Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline

Time frame:
Baseline and Week 12
Reported as:
Mean · mmHg
Mean Change in Intraocular Pressure at Week 12 From Baseline
mmHgPost-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2
Mean Change in Intraocular Pressure at Week 12 From Baseline2.6 ± 1.23.3 ± 1.40.3 ± 1.61.5 ± 1.4
SecondaryMean 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.

Time frame:
Week 12 and Week 48
Reported as:
Mean · Letters
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
LettersPrednisolone Acetate Switched From 4 Hours to Every 1 HourPrednisolone Acetate Continued Every 1 HourPrednisolone Acetate Switched From Every 1 Hour to 4 Hours
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 489.3 ± 2.55.4 ± 2.110.8 ± 5.1
SecondaryMean 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

Time frame:
Week 12 and Week 48
Reported as:
Mean · µm
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
µmPrednisolone Acetate Switched From 4 Hours to Every 1 HourPrednisolone Acetate Continued Every 1 HourPrednisolone Acetate Switched From Every 1 Hour to 4 Hours
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48-109.7 ± 50.9-44.0 ± 20.8-1.3 ± 6.2
SecondaryMean Change in Intraocular Pressure Between Week 12 and Week 24

Mean Change in Intraocular Pressure (IOP) between week 12 and week 24

Time frame:
Week 12 and Week 48
Reported as:
Mean · mmHg
Mean Change in Intraocular Pressure Between Week 12 and Week 24
mmHgPrednisolone Acetate Switched From 4 Hours to Every 1 HourPrednisolone Acetate Continued Every 1 HourPrednisolone Acetate Switched From Every 1 Hour to 4 Hours
Mean Change in Intraocular Pressure Between Week 12 and Week 242.3 ± 2.50.0 ± 1.7-4.7 ± 4.0

Adverse events

Collected over 48 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prednisolone Acetate Every 1 Hour While Awake (Group 1)0/22 (0%)5/22 (22.7%)6/22 (27.3%)
Prednisolone Acetate Four Times a Day (Group 2)0/20 (0%)4/20 (20%)9/20 (45%)
Most frequent serious events
Most frequent serious events
EventPrednisolone Acetate Every 1 Hour While Awake (Group 1)Prednisolone Acetate Four Times a Day (Group 2)
PneumoniaRespiratory, thoracic and mediastinal disorders1/221/20
Periodontal surgeryGeneral disorders1/221/20
Cataract Surgery due to progression of cataractEye disorders1/221/20
Intraocular Pressure Lowering SurgeryEye disorders0/221/20
Retinal DetachmentEye disorders1/220/20
EndophthalmitisEye disorders1/220/20
Blood transfusion due to severe anemiaBlood and lymphatic system disorders1/220/20
Surgery for resection of Zenker's DiverticulumGastrointestinal disorders1/220/20
Most frequent other events
Most frequent other events
EventPrednisolone Acetate Every 1 Hour While Awake (Group 1)Prednisolone Acetate Four Times a Day (Group 2)
Increase in Intraocular PressureEye disorders3/225/20
Upper Respiratory Tract InfectionsRespiratory, thoracic and mediastinal disorders3/224/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
Mean70.4 ± 2.069.9 ± 2.466.2 ± 1.960.1 ± 4.867.4 ± 1.4
Sex: Female, Male
Sex: Female, Male(Participants)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
Female678526
Male751316
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American44019
White888731
More than one race00000
Unknown or Not Reported10102
Region of Enrollment
Region of Enrollment(participants)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
United States13129842
Number of Surgeries at the Time of Enrollment, mean+SEM
Number of Surgeries at the Time of Enrollment, mean+SEM(surgeries)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
Mean1.8 ± 0.21.4 ± 0.22.1 ± 0.42.1 ± 0.31.8 ± 0.1
Best Corrected Visual Acuity at Baseline mean+SEM (Letter Score)
Best Corrected Visual Acuity at Baseline mean+SEM (Letter Score)(letters)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
Mean55.7 (31 to 80)60.9 (29 to 75)53.4 (19 to 68)50.9 (20 to 73)55.8 (19 to 80)
CST at Baseline, mean+SEM (µm)
CST at Baseline, mean+SEM (µm)(µm)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
Mean515.5 ± 33.9447.6 ± 33.9487.3 ± 33.3489.1 ± 29.5485.0 ± 16.9
IOP at Baseline, mean+SEM (mmHg)
IOP at Baseline, mean+SEM (mmHg)(mmHg)Post-Cataract Surgery Macular Edema- Group 1Post-Cataract Surgery Macular Edema- Group 2Post-Other Surgery Macular Edema- Group 1Post-Other Surgery Macular Edema- Group 2Total
Mean14.2 ± 1.315.6 ± 0.814.8 ± 0.916.0 ± 2.215.1 ± 0.6
08

Study locations

1 site
  • Wilmer Eye Institute
    Baltimore, Maryland 21287, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01769352
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Jan 16, 2013
Start date
Aug 2012
Primary completion
Apr 2016
Completion
Apr 2016
Results posted
Sep 15, 2017
Last update
Sep 15, 2017

Study contacts

Peter A Campochiaro, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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