Trial Outcomes & Findings for Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1) (NCT NCT01769352)
NCT ID: NCT01769352
Last Updated: 2017-09-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
42 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1
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.
|
Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2
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.
|
Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1
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.
|
Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
9
|
8
|
|
Overall Study
COMPLETED
|
13
|
12
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
Baseline characteristics by cohort
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=13 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=12 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=9 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
n=8 Participants
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
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
69.9 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
67.4 years
STANDARD_DEVIATION 1.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
42 participants
n=21 Participants
|
|
Number of Surgeries at the Time of Enrollment, mean+SEM
|
1.8 surgeries
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.4 surgeries
STANDARD_DEVIATION 0.2 • n=7 Participants
|
2.1 surgeries
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.1 surgeries
STANDARD_DEVIATION 0.3 • n=4 Participants
|
1.8 surgeries
STANDARD_DEVIATION 0.1 • n=21 Participants
|
|
Best Corrected Visual Acuity at Baseline mean+SEM (Letter Score)
|
55.7 letters
n=5 Participants
|
60.9 letters
n=7 Participants
|
53.4 letters
n=5 Participants
|
50.9 letters
n=4 Participants
|
55.8 letters
n=21 Participants
|
|
CST at Baseline, mean+SEM (µm)
|
515.5 µm
STANDARD_DEVIATION 33.9 • n=5 Participants
|
447.6 µm
STANDARD_DEVIATION 33.9 • n=7 Participants
|
487.3 µm
STANDARD_DEVIATION 33.3 • n=5 Participants
|
489.1 µm
STANDARD_DEVIATION 29.5 • n=4 Participants
|
485.0 µm
STANDARD_DEVIATION 16.9 • n=21 Participants
|
|
IOP at Baseline, mean+SEM (mmHg)
|
14.2 mmHg
STANDARD_DEVIATION 1.3 • n=5 Participants
|
15.6 mmHg
STANDARD_DEVIATION 0.8 • n=7 Participants
|
14.8 mmHg
STANDARD_DEVIATION 0.9 • n=5 Participants
|
16.0 mmHg
STANDARD_DEVIATION 2.2 • n=4 Participants
|
15.1 mmHg
STANDARD_DEVIATION 0.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Mean 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.
Outcome measures
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=13 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=12 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=9 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
n=8 Participants
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)
|
|---|---|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
|
10.6 letters
Standard Error 2.6
|
7.8 letters
Standard Error 3.4
|
13.1 letters
Standard Error 3.4
|
9.4 letters
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline
Outcome measures
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=13 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=12 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=8 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
n=8 Participants
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)
|
|---|---|---|---|---|
|
Mean Change in Central Subfield Thickness at Week 12 From Baseline
|
-152.7 µm
Standard Error 33.5
|
-56.4 µm
Standard Error 21.0
|
-25.9 µm
Standard Error 25.7
|
-75.0 µm
Standard Error 30.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
Outcome measures
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=13 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=12 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=9 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
n=8 Participants
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)
|
|---|---|---|---|---|
|
Mean Change in Intraocular Pressure at Week 12 From Baseline
|
2.6 mmHg
Standard Error 1.2
|
3.3 mmHg
Standard Error 1.4
|
0.3 mmHg
Standard Error 1.6
|
1.5 mmHg
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Week 12 and Week 48Mean 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.
Outcome measures
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=7 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=7 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=6 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
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)
|
|---|---|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
|
9.3 Letters
Standard Error 2.5
|
5.4 Letters
Standard Error 2.1
|
10.8 Letters
Standard Error 5.1
|
—
|
SECONDARY outcome
Timeframe: Week 12 and Week 48Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48
Outcome measures
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=7 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=7 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=6 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
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)
|
|---|---|---|---|---|
|
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
|
-109.7 µm
Standard Error 50.9
|
-44.0 µm
Standard Error 20.8
|
-1.3 µm
Standard Error 6.2
|
—
|
SECONDARY outcome
Timeframe: Week 12 and Week 48Mean Change in Intraocular Pressure (IOP) between week 12 and week 24
Outcome measures
| Measure |
Post-Cataract Surgery Macular Edema- Group 1
n=7 Participants
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)
|
Post-Cataract Surgery Macular Edema- Group 2
n=7 Participants
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)
|
Post-Other Surgery Macular Edema- Group 1
n=6 Participants
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)
|
Post-Other Surgery Macular Edema- Group 2
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)
|
|---|---|---|---|---|
|
Mean Change in Intraocular Pressure Between Week 12 and Week 24
|
2.3 mmHg
Standard Error 2.5
|
0.0 mmHg
Standard Error 1.7
|
-4.7 mmHg
Standard Error 4.0
|
—
|
Adverse Events
Prednisolone Acetate Every 1 Hour While Awake (Group 1)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Prednisolone Acetate Four Times a Day (Group 2)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prednisolone Acetate Every 1 Hour While Awake (Group 1)
n=22 participants at risk
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.
|
Prednisolone Acetate Four Times a Day (Group 2)
n=20 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Retinal Detachment
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
0.00%
0/20 • 48 Weeks
|
|
Eye disorders
Endophthalmitis
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
0.00%
0/20 • 48 Weeks
|
|
Blood and lymphatic system disorders
Blood transfusion due to severe anemia
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
0.00%
0/20 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
5.0%
1/20 • Number of events 1 • 48 Weeks
|
|
General disorders
Periodontal surgery
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
5.0%
1/20 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
Surgery for resection of Zenker's Diverticulum
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
0.00%
0/20 • 48 Weeks
|
|
Eye disorders
Cataract Surgery due to progression of cataract
|
4.5%
1/22 • Number of events 1 • 48 Weeks
|
5.0%
1/20 • Number of events 1 • 48 Weeks
|
|
Eye disorders
Intraocular Pressure Lowering Surgery
|
0.00%
0/22 • 48 Weeks
|
5.0%
1/20 • Number of events 1 • 48 Weeks
|
Other adverse events
| Measure |
Prednisolone Acetate Every 1 Hour While Awake (Group 1)
n=22 participants at risk
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.
|
Prednisolone Acetate Four Times a Day (Group 2)
n=20 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Increase in Intraocular Pressure
|
13.6%
3/22 • Number of events 3 • 48 Weeks
|
25.0%
5/20 • Number of events 5 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infections
|
13.6%
3/22 • Number of events 3 • 48 Weeks
|
20.0%
4/20 • Number of events 4 • 48 Weeks
|
Additional Information
Dr. Peter A. Campochiaro
Johns Hopkins University School of Medicine
Phone: 410-955-5106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place