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Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.

Effect of Topical Aqueous Suppressants on Response to Intravitreal Anti-vascular Endothelial Growth Factor Injections in Age-related Macular Degeneration (AMD), Retinal Vein Occlusions (RVO) or Diabetic Macular Edema (DME).

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02571972
Enrollment
14
Registered
2015-10-08
Start date
2015-02-01
Completion date
2015-12-20
Last updated
2019-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, Wet Macular Degeneration

Keywords

dorzolamide-timolol, topical aqueous suppression, neovascular age-related macular degeneration, macular edema, intravitreal injection, anti-vascular endothelial growth factor

Brief summary

This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in non-responders with wet age-related macular degeneration.

Detailed description

Intravitreal anti-vascular endothelial growth factor (VEGF) agents, including bevacizumab, ranibizumab, and aflibercept, have become the gold standard treatment for neovascular age-related macular degeneration (AMD). Various treatment modalities using these agents have been proposed, including monthly, pro re nata, and treat-and-extend philosophies. Despite frequent and consistent treatment with anti-VEGF therapy, there is a subset of patients who are incomplete or non-responders and have persistent evidence of exudation on spectral-domain optical coherence tomography (SD-OCT), including subretinal fluid (SRF) and/or intraretinal edema. While clearance of intravitreal anti-VEGF drugs is not completely understood, some studies have suggested that outflow through the anterior chamber may contribute. We hypothesized that by decreasing aqueous production, outflow may also be reduced which could delay the clearance of intravitreal drugs. As a result, we chose topical dorzolamide-timolol since it is a potent aqueous suppressant and is readily available due to its common use in the treatment of glaucoma. The current study aimed to evaluate the efficacy of topical dorzolamide-timolol on anatomic and visual outcomes in anti-VEGF non-responders with neovascular AMD. Significance: The results of this study will help delineate whether topical aqueous suppression may be useful as adjuvant therapy in patients receiving chronic intravitreal anti-VEGF injections.

Interventions

DRUGDorzolamide-timolol

On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration

Sponsors

J. Arch McNamara Research Fund
CollaboratorOTHER
Mid Atlantic Retina
CollaboratorOTHER
Wills Eye
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina. 2. Volunteer patients age 18 years and older. 3. Healthy enough to participate in the study. 4. Willing and able to consent to participation in the study. 5. Diagnosis of wet age-related macular degeneration 6. Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period 7. Injection of the same anti-VEGF agent for at least two visits prior to study enrollment 8. Fixed interval between at least two visits prior to study enrollment

Exclusion criteria

1. History of uveitis 2. Any ophthalmic surgery within previous 6 months, including cataract extraction. 3. Any history of vitrectomy 4. History of any glaucoma drop usage or prior glaucoma surgery 5. Systemic diuretic or corticosteroid usage 6. Any contraindication (bradycardia, decompensated heart failure, or reactive 7. airway disease) for topical use of a beta-blocker 8. Any history of sulfonamide allergy \-

Design outcomes

Primary

MeasureTime frameDescription
Mean Central Subfield Thickness (CST)3 visits (8-12 weeks)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

Secondary

MeasureTime frameDescription
Visual Acuity3 visits (8-12 weeks)LogMAR Visual acuity on enrollment and final visit
Maximum Subretinal Fluid Height3 visits (8-12 weeks)Measurement based on SD-OCT
Maximum Pigment Epithelial Detachment Height3 visits (8-12 weeks)Measurement based on SD-OCT

Countries

United States

Participant flow

Participants by arm

ArmCount
Dorzolamide-timolol
* 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
10
Dorzolamide-timolol
* 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
10
Total20

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyProtocol Violation2
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicDorzolamide-timolol
Age, Continuous78.2 years
Current treatment interval
Every 4 weeks
8 Eyes
Current treatment interval
Every 5 weeks
1 Eyes
Current treatment interval
Every 6 weeks
1 Eyes
Intravitreous anti-vascular endothelial growth factor (VEGF) agent
Aflibercept
8 Eyes
Intravitreous anti-vascular endothelial growth factor (VEGF) agent
Ranibizumab
2 Eyes
Prior injections with same anti-VEGF drug21.9 Injections
Pseudophakic8 Eyes
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 14
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 14

Outcome results

Primary

Mean Central Subfield Thickness (CST)

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

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Dorzolamide-timololMean Central Subfield Thickness (CST)Study visit 3326.9 micronsStandard Deviation 115.5
Dorzolamide-timololMean Central Subfield Thickness (CST)Final visit334.1 micronsStandard Deviation 103
Dorzolamide-timololMean Central Subfield Thickness (CST)Pre-enrollment visit422.9 micronsStandard Deviation 100.9
Dorzolamide-timololMean Central Subfield Thickness (CST)Enrollment visit419.7 micronsStandard Deviation 95.9
Dorzolamide-timololMean Central Subfield Thickness (CST)Study visit 1364.5 micronsStandard Deviation 76.3
Dorzolamide-timololMean Central Subfield Thickness (CST)Study visit 2346.7 micronsStandard Deviation 99.9
Secondary

Maximum Pigment Epithelial Detachment Height

Measurement based on SD-OCT

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Dorzolamide-timololMaximum Pigment Epithelial Detachment HeightPre-enrollment visit275.4 micronsStandard Deviation 170.7
Dorzolamide-timololMaximum Pigment Epithelial Detachment HeightEnrollment visit277.4 micronsStandard Deviation 174.9
Dorzolamide-timololMaximum Pigment Epithelial Detachment HeightStudy visit 1258.9 micronsStandard Deviation 173.7
Dorzolamide-timololMaximum Pigment Epithelial Detachment HeightStudy visit 2227.8 micronsStandard Deviation 163
Dorzolamide-timololMaximum Pigment Epithelial Detachment HeightStudy visit 3275.4 micronsStandard Deviation 160.8
Dorzolamide-timololMaximum Pigment Epithelial Detachment HeightFinal visit239.9 micronsStandard Deviation 163
Secondary

Maximum Subretinal Fluid Height

Measurement based on SD-OCT

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Dorzolamide-timololMaximum Subretinal Fluid HeightPre-enrollment visit111.5 micronsStandard Deviation 101.3
Dorzolamide-timololMaximum Subretinal Fluid HeightEnrollment visit126.6 micronsStandard Deviation 78.2
Dorzolamide-timololMaximum Subretinal Fluid HeightStudy visit 177.9 micronsStandard Deviation 70.7
Dorzolamide-timololMaximum Subretinal Fluid HeightStudy visit 262.0 micronsStandard Deviation 59.7
Dorzolamide-timololMaximum Subretinal Fluid HeightStudy visit 356.5 micronsStandard Deviation 58
Dorzolamide-timololMaximum Subretinal Fluid HeightFinal visit49.5 micronsStandard Deviation 54.1
Secondary

Visual Acuity

LogMAR Visual acuity on enrollment and final visit

Time frame: 3 visits (8-12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Dorzolamide-timololVisual AcuityBaseline0.54 logMARStandard Deviation 0.53
Dorzolamide-timololVisual AcuityFinal0.48 logMARStandard Deviation 0.29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026