Trial Outcomes & Findings for Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-related Macular Degeneration (NCT NCT03034772)
NCT ID: NCT03034772
Last Updated: 2020-06-19
Results Overview
Change in mean CST on spectral domain optical coherence tomography from baseline to the final visit
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Baseline and 18 weeks
Results posted on
2020-06-19
Participant Flow
Since multiple centers were enrolling simultaneously, two more patients then anticipated were randomized
Participant milestones
| Measure |
Dorzolamide-timolol
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Dorzolamide-timolol
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dorzolamide-timolol
n=27 Participants
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=23 Participants
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.7 years
STANDARD_DEVIATION 7.5 • n=27 Participants
|
77.5 years
STANDARD_DEVIATION 6.3 • n=23 Participants
|
78.4 years
STANDARD_DEVIATION 7 • n=50 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=27 Participants
|
16 Participants
n=23 Participants
|
34 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=27 Participants
|
7 Participants
n=23 Participants
|
16 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
27 Participants
n=27 Participants
|
23 Participants
n=23 Participants
|
50 Participants
n=50 Participants
|
|
Intravitreal anti-vascular endothelial growth factor agent used
Aflibercept
|
13 Participants
n=27 Participants
|
14 Participants
n=23 Participants
|
27 Participants
n=50 Participants
|
|
Intravitreal anti-vascular endothelial growth factor agent used
Ranibizumab
|
14 Participants
n=27 Participants
|
9 Participants
n=23 Participants
|
23 Participants
n=50 Participants
|
|
Number of prior anti-vascular endothelial growth factor (VEGF) injections
|
20 injections
STANDARD_DEVIATION 15.6 • n=27 Participants
|
21.1 injections
STANDARD_DEVIATION 11.6 • n=23 Participants
|
20.5 injections
STANDARD_DEVIATION 14 • n=50 Participants
|
|
Injection interval before enrollment
Every 4 weeks
|
17 Participants
n=27 Participants
|
12 Participants
n=23 Participants
|
29 Participants
n=50 Participants
|
|
Injection interval before enrollment
Every 5 weeks
|
3 Participants
n=27 Participants
|
8 Participants
n=23 Participants
|
11 Participants
n=50 Participants
|
|
Injection interval before enrollment
Every 6 weeks
|
7 Participants
n=27 Participants
|
3 Participants
n=23 Participants
|
10 Participants
n=50 Participants
|
|
Visual Acuity (logarithm of the minimum angle of resolution, logMAR)
|
0.37 logMAR
STANDARD_DEVIATION 0.31 • n=27 Participants
|
0.348 logMAR
STANDARD_DEVIATION 0.19 • n=23 Participants
|
0.361 logMAR
STANDARD_DEVIATION 0.26 • n=50 Participants
|
|
Intraocular Pressure
|
14.37 mm Hg
STANDARD_DEVIATION 2.9 • n=27 Participants
|
14.22 mm Hg
STANDARD_DEVIATION 3.1 • n=23 Participants
|
14.3 mm Hg
STANDARD_DEVIATION 2.95 • n=50 Participants
|
|
Baseline Optical Coherence Tomography (OCT) Measurements
Central subfield thickness
|
348.3 microns
STANDARD_DEVIATION 75.5 • n=27 Participants
|
321.3 microns
STANDARD_DEVIATION 80.5 • n=23 Participants
|
335.9 microns
STANDARD_DEVIATION 78.2 • n=50 Participants
|
|
Baseline Optical Coherence Tomography (OCT) Measurements
Maximum pigment epithelial detachment height
|
230.2 microns
STANDARD_DEVIATION 116.4 • n=27 Participants
|
178.9 microns
STANDARD_DEVIATION 111 • n=23 Participants
|
206.1 microns
STANDARD_DEVIATION 115.7 • n=50 Participants
|
|
Baseline Optical Coherence Tomography (OCT) Measurements
Maximum subretinal fluid height
|
103.15 microns
STANDARD_DEVIATION 68.5 • n=27 Participants
|
90 microns
STANDARD_DEVIATION 70.5 • n=23 Participants
|
96.98 microns
STANDARD_DEVIATION 69.1 • n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18 weeksChange in mean CST on spectral domain optical coherence tomography from baseline to the final visit
Outcome measures
| Measure |
Dorzolamide-timolol
n=27 Participants
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=23 Participants
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Change in Mean Central Subfield Thickness (CST)
|
-36.6 microns
Standard Deviation 54
|
1.7 microns
Standard Deviation 52.3
|
SECONDARY outcome
Timeframe: Baseline and 18 weeksChange in mean maximum SRF height on spectral domain optical coherence tomography from baseline to final visit.
Outcome measures
| Measure |
Dorzolamide-timolol
n=27 Participants
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=23 Participants
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Change in Mean Maximum Subretinal Fluid (SRF) Height
|
-49.4 microns
Standard Deviation 55
|
-22.2 microns
Standard Deviation 56
|
SECONDARY outcome
Timeframe: Baseline and 18 weeksChange in mean maximum PED height on spectral domain optical coherence tomography from baseline to final visit.
Outcome measures
| Measure |
Dorzolamide-timolol
n=27 Participants
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=23 Participants
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Change in Mean Maximum Pigment Epithelial Detachment (PED) Height
|
-39.1 microns
Standard Deviation 65
|
1.1 microns
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Baseline and 18 weeksChange in mean best available visual acuity from baseline to final visit.
Outcome measures
| Measure |
Dorzolamide-timolol
n=27 Participants
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=23 Participants
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Change in Visual Acuity
|
0.031 logMAR
Standard Deviation 0.15
|
0.018 logMAR
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline and 18 weeksChange in mean IOP from baseline to final visit.
Outcome measures
| Measure |
Dorzolamide-timolol
n=27 Participants
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=23 Participants
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Change in Mean Intraocular Pressure (IOP)
|
-1.81 mm Hg
Standard Deviation 3.8
|
-0.78 mm Hg
Standard Deviation 2.8
|
Adverse Events
Dorzolamide-timolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artificial Tears
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dorzolamide-timolol
n=27 participants at risk
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration
|
Artificial Tears
n=25 participants at risk
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration
|
|---|---|---|
|
Eye disorders
Eyelid edema
|
0.00%
0/27 • 20 months
|
4.0%
1/25 • Number of events 1 • 20 months
|
Additional Information
Jason Hsu, MD
Wills Eye Physicians, Mid Atlantic Retina
Phone: 215-928-3092
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place