Trial Outcomes & Findings for Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration (NCT NCT00716586)

Results Overview

Foveal thickness measured by OCT. A 17% or greater reduction in foveal thickness was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

Baseline and most recent visit (2 month up to 36 months)

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Trusopt (2 % Dorzolamide). Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day.
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Form of Carbonic Anhydrase Inhibitor. n=44 Participants Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt. dorzolamide: 2% dorzolamide- 1 Gtt TID
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and most recent visit (2 month up to 36 months)

Population: Intent to treat population (all participants assigned to Trusopt (2% dorzolamide).

Foveal thickness measured by OCT. A 17% or greater reduction in foveal thickness was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

Outcome measures

Outcome measures
Measure	Trusopt (2% Dorzolamide) n=44 Participants Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day
Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)	36 participants

PRIMARY outcome

Timeframe: Baseline and most recent visit (2 months up to 36 months)

Population: Intent to treat population (all participants assigned to Trusopt (2% dorzolamide).

Macular fluid measured subjectively by OCT. A 25% or greater reduction of macular fluid was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

Outcome measures

Outcome measures
Measure	Trusopt (2% Dorzolamide) n=44 Participants Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day
Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)	36 participants

SECONDARY outcome

Timeframe: Baseline and most recent visit (2 months up to 36 months)

Population: Intent to treat population (all participants assigned to Trusopt (2 % dorzolamide).

Visual acuity measured in LogMAR units. Reading 7 letters or more on a visual chart, from baseline to most recent visit, was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

Outcome measures

Outcome measures
Measure	Trusopt (2% Dorzolamide) n=44 Participants Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day
Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart	20 participants

Adverse Events

Topical Form of Carbonic Anhydrase Inhibitor

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

Emeritus Professor of Ophthalmology

University of Illinois at Chicago

Phone: 312 997-3646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place