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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01769352
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 1

Study Details

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• 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)
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline [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

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

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

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

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

3. Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 [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.

4. Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 [Week 12 and Week 48]

   Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48

5. Mean Change in Intraocular Pressure Between Week 12 and Week 24 [Week 12 and Week 48]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Locations

	Site	City	State	Country	Postal Code
1	Wilmer Eye Institute	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Peter A Campochiaro, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01769352
• Other Study ID Numbers: NA_00074523
• First Posted: Jan 16, 2013
• Last Update Posted: Sep 15, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Johns Hopkins University: cystoid macular edema
• Additional relevant MeSH terms: Macular Edema; Edema; Prednisolone acetate

Study Results

Participant Flow

Arm/Group Title	Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1	Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2	Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1	Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2
Arm/Group Description	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) 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 withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) 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 withdrawal. 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.	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) 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 withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) 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 withdrawal. 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.
Period Title: Overall Study
STARTED	13	12	9	8
COMPLETED	13	12	9	8
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Post-Cataract Surgery Macular Edema- Group 1	Post-Cataract Surgery Macular Edema- Group 2	Post-Other Surgery Macular Edema- Group 1	Post-Other Surgery Macular Edema- Group 2	Total
Arm/Group Description	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Total of all reporting groups
Overall Participants	13	12	9	8	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.4 (2.0)	69.9 (2.4)	66.2 (1.9)	60.1 (4.8)	67.4 (1.4)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	7 58.3%	8 88.9%	5 62.5%	26 61.9%
Male	7 53.8%	5 41.7%	1 11.1%	3 37.5%	16 38.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	4 30.8%	4 33.3%	0 0%	1 12.5%	9 21.4%
White	8 61.5%	8 66.7%	8 88.9%	7 87.5%	31 73.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 7.7%	0 0%	1 11.1%	0 0%	2 4.8%
Region of Enrollment (participants) [Number]
United States	13 100%	12 100%	9 100%	8 100%	42 100%
Number of Surgeries at the Time of Enrollment, mean+SEM (surgeries) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [surgeries]	1.8 (0.2)	1.4 (0.2)	2.1 (0.4)	2.1 (0.3)	1.8 (0.1)
Best Corrected Visual Acuity at Baseline mean+SEM (Letter Score) (letters) [Mean (Full Range) ]
Mean (Full Range) [letters]	55.7	60.9	53.4	50.9	55.8
CST at Baseline, mean+SEM (µm) (µm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µm]	515.5 (33.9)	447.6 (33.9)	487.3 (33.3)	489.1 (29.5)	485.0 (16.9)
IOP at Baseline, mean+SEM (mmHg) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	14.2 (1.3)	15.6 (0.8)	14.8 (0.9)	16.0 (2.2)	15.1 (0.6)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Post-Cataract Surgery Macular Edema- Group 1	Post-Cataract Surgery Macular Edema- Group 2	Post-Other Surgery Macular Edema- Group 1	Post-Other Surgery Macular Edema- Group 2
Arm/Group Description	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
Measure Participants	13	12	9	8
Mean (Standard Error) [letters]	10.6 (2.6)	7.8 (3.4)	13.1 (3.4)	9.4 (3.6)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Post-Cataract Surgery Macular Edema- Group 1	Post-Cataract Surgery Macular Edema- Group 2	Post-Other Surgery Macular Edema- Group 1	Post-Other Surgery Macular Edema- Group 2
Arm/Group Description	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
Measure Participants	13	12	8	8
Mean (Standard Error) [µm]	-152.7 (33.5)	-56.4 (21.0)	-25.9 (25.7)	-75.0 (30.7)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Post-Cataract Surgery Macular Edema- Group 1	Post-Cataract Surgery Macular Edema- Group 2	Post-Other Surgery Macular Edema- Group 1	Post-Other Surgery Macular Edema- Group 2
Arm/Group Description	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)	Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid)
Measure Participants	13	12	9	8
Mean (Standard Error) [mmHg]	2.6 (1.2)	3.3 (1.4)	0.3 (1.6)	1.5 (1.4)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisolone Acetate Switched From 4 Hours to Every 1 Hour	Prednisolone Acetate Continued Every 1 Hour	Prednisolone Acetate Switched From Every 1 Hour to 4 Hours
Arm/Group Description	Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.	Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.	Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
Measure Participants	7	7	6
Mean (Standard Error) [Letters]	9.3 (2.5)	5.4 (2.1)	10.8 (5.1)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisolone Acetate Switched From 4 Hours to Every 1 Hour	Prednisolone Acetate Continued Every 1 Hour	Prednisolone Acetate Switched From Every 1 Hour to 4 Hours
Arm/Group Description	Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.	Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.	Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
Measure Participants	7	7	6
Mean (Standard Error) [µm]	-109.7 (50.9)	-44.0 (20.8)	-1.3 (6.2)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisolone Acetate Switched From 4 Hours to Every 1 Hour	Prednisolone Acetate Continued Every 1 Hour	Prednisolone Acetate Switched From Every 1 Hour to 4 Hours
Arm/Group Description	Patients who switched from Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hours to every 1 hour while awake at week 12.	Patients who continued on Prednisolone Acetate (PredA) 1% ophthalmic solution continued every 1 hour while awake at week 12.	Patients who switched from Prednisolone Acetate (PredA) 1% ophthalmic solution from every 1 hours while awake to every 4 hours at week 12.
Measure Participants	7	7	6
Mean (Standard Error) [mmHg]	2.3 (2.5)	0.0 (1.7)	-4.7 (4.0)

Adverse Events

Time Frame	48 Weeks
Arm/Group Title	Prednisolone Acetate Every 1 Hour While Awake (Group 1)		Prednisolone Acetate Four Times a Day (Group 2)
Arm/Group Description	Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution every 1 hour while awake. Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA every 1 hour (q1h) - Group 1.		Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution four times a day Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA four times a day (qid) - Group 2.
All Cause Mortality
	Prednisolone Acetate Every 1 Hour While Awake (Group 1)		Prednisolone Acetate Four Times a Day (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/20 (0%)
Serious Adverse Events
	Prednisolone Acetate Every 1 Hour While Awake (Group 1)		Prednisolone Acetate Four Times a Day (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/22 (22.7%)		4/20 (20%)
Blood and lymphatic system disorders
Blood transfusion due to severe anemia	1/22 (4.5%)	1	0/20 (0%)	0
Eye disorders
Retinal Detachment	1/22 (4.5%)	1	0/20 (0%)	0
Endophthalmitis	1/22 (4.5%)	1	0/20 (0%)	0
Cataract Surgery due to progression of cataract	1/22 (4.5%)	1	1/20 (5%)	1
Intraocular Pressure Lowering Surgery	0/22 (0%)	0	1/20 (5%)	1
Gastrointestinal disorders
Surgery for resection of Zenker's Diverticulum	1/22 (4.5%)	1	0/20 (0%)	0
General disorders
Periodontal surgery	1/22 (4.5%)	1	1/20 (5%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/22 (4.5%)	1	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Prednisolone Acetate Every 1 Hour While Awake (Group 1)		Prednisolone Acetate Four Times a Day (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/22 (27.3%)		9/20 (45%)
Eye disorders
Increase in Intraocular Pressure	3/22 (13.6%)	3	5/20 (25%)	5
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infections	3/22 (13.6%)	3	4/20 (20%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.