Trial Outcomes & Findings for Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME. (NCT NCT02571972)
NCT ID: NCT02571972
Last Updated: 2019-12-03
Results Overview
Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
3 visits (8-12 weeks)
Results posted on
2019-12-03
Participant Flow
Participant milestones
| Measure |
Dorzolamide-timolol
On enrollment, eligible patients will be started on topical dorzolamide 2%-timolol 0.5% 1 drop in the study eye twice daily for the study duration
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Dorzolamide-timolol
On enrollment, eligible patients will be started on topical dorzolamide 2%-timolol 0.5% 1 drop in the study eye twice daily for the study duration
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.
Baseline characteristics by cohort
| Measure |
Dorzolamide-timolol
n=10 Eyes
* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.
* Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.
* Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits
* At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
|
|---|---|
|
Age, Continuous
|
78.2 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
|
Intravitreous anti-vascular endothelial growth factor (VEGF) agent
Aflibercept
|
8 Eyes
n=10 Eyes
|
|
Intravitreous anti-vascular endothelial growth factor (VEGF) agent
Ranibizumab
|
2 Eyes
n=10 Eyes
|
|
Prior injections with same anti-VEGF drug
|
21.9 Injections
n=10 Eyes
|
|
Pseudophakic
|
8 Eyes
n=10 Eyes
|
|
Current treatment interval
Every 4 weeks
|
8 Eyes
n=10 Eyes
|
|
Current treatment interval
Every 5 weeks
|
1 Eyes
n=10 Eyes
|
|
Current treatment interval
Every 6 weeks
|
1 Eyes
n=10 Eyes
|
PRIMARY outcome
Timeframe: 3 visits (8-12 weeks)Population: Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2.
Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment
Outcome measures
| Measure |
Dorzolamide-timolol
n=10 Participants
* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.
* Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.
* Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits
* At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
|
|---|---|
|
Mean Central Subfield Thickness (CST)
Pre-enrollment visit
|
422.9 microns
Standard Deviation 100.9
|
|
Mean Central Subfield Thickness (CST)
Enrollment visit
|
419.7 microns
Standard Deviation 95.9
|
|
Mean Central Subfield Thickness (CST)
Study visit 1
|
364.5 microns
Standard Deviation 76.3
|
|
Mean Central Subfield Thickness (CST)
Study visit 2
|
346.7 microns
Standard Deviation 99.9
|
|
Mean Central Subfield Thickness (CST)
Study visit 3
|
326.9 microns
Standard Deviation 115.5
|
|
Mean Central Subfield Thickness (CST)
Final visit
|
334.1 microns
Standard Deviation 103.0
|
SECONDARY outcome
Timeframe: 3 visits (8-12 weeks)LogMAR Visual acuity on enrollment and final visit
Outcome measures
| Measure |
Dorzolamide-timolol
n=10 Eyes
* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.
* Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.
* Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits
* At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
|
|---|---|
|
Visual Acuity
Baseline
|
0.54 logMAR
Standard Deviation 0.53
|
|
Visual Acuity
Final
|
0.48 logMAR
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 3 visits (8-12 weeks)Population: Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2.
Measurement based on SD-OCT
Outcome measures
| Measure |
Dorzolamide-timolol
n=10 Eyes
* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.
* Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.
* Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits
* At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
|
|---|---|
|
Maximum Subretinal Fluid Height
Pre-enrollment visit
|
111.5 microns
Standard Deviation 101.3
|
|
Maximum Subretinal Fluid Height
Enrollment visit
|
126.6 microns
Standard Deviation 78.2
|
|
Maximum Subretinal Fluid Height
Study visit 1
|
77.9 microns
Standard Deviation 70.7
|
|
Maximum Subretinal Fluid Height
Study visit 2
|
62.0 microns
Standard Deviation 59.7
|
|
Maximum Subretinal Fluid Height
Study visit 3
|
56.5 microns
Standard Deviation 58.0
|
|
Maximum Subretinal Fluid Height
Final visit
|
49.5 microns
Standard Deviation 54.1
|
SECONDARY outcome
Timeframe: 3 visits (8-12 weeks)Population: Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2.
Measurement based on SD-OCT
Outcome measures
| Measure |
Dorzolamide-timolol
n=10 Eyes
* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.
* Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.
* Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits
* At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
|
|---|---|
|
Maximum Pigment Epithelial Detachment Height
Pre-enrollment visit
|
275.4 microns
Standard Deviation 170.7
|
|
Maximum Pigment Epithelial Detachment Height
Enrollment visit
|
277.4 microns
Standard Deviation 174.9
|
|
Maximum Pigment Epithelial Detachment Height
Study visit 1
|
258.9 microns
Standard Deviation 173.7
|
|
Maximum Pigment Epithelial Detachment Height
Study visit 2
|
227.8 microns
Standard Deviation 163.0
|
|
Maximum Pigment Epithelial Detachment Height
Study visit 3
|
275.4 microns
Standard Deviation 160.8
|
|
Maximum Pigment Epithelial Detachment Height
Final visit
|
239.9 microns
Standard Deviation 163.0
|
Adverse Events
Dorzolamide-timolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jason Hsu
Retina Service of Wills Eye Hospital, Mid Atlantic Retina
Phone: 215-928-3092
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place