Retinal Degenerations
Conditions
Brief summary
A small percentage of patients with retinal degeneration accumulate fluid in the center of their retina. Previous studies using an oral form of treatment has been successful in decreasing this fluid which improves vision. This study will test the use of a topically applied form of this treatment to the eye to reduce the amount of fluid and improve or preserve vision.
Detailed description
Patients with certain retinal degenerations will be asked to take part in a research study about the use of a topically applied eye drop for treating fluid in the central part of the retina (macular edema). In the current study, investigators propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its effectiveness in reducing the amount of retinal fluid in patients with RD and macular edema. The methods will involve an initial one month treatment with topical Trusopt three times a day in each eye. After a period of one month, patients will return for a follow-up examination. At baseline, they will have had a measurement of their center vision and a measurement of their macular fluid with a photographic-like procedure termed optical coherence tomography (OCT). After the one month period of treatment, they will again have a measurement of their vision and re-evaluation with OCT. An improvement at least of one line (7 letters) or more of vision will be considered as a clinically significant improvement.
Interventions
DRUG2% dorzolamide
Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)
Sponsors
University of Illinois at Chicago
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
* Presence of cystic macular fluid on OCT testing
Exclusion criteria
* Allergic reaction to sulpha containing compounds * Intolerance to dorzolamide (Trusopt)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT) | Baseline and most recent visit (2 month up to 36 months) | 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. |
| Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT) | Baseline and most recent visit (2 months up to 36 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart | Baseline and most recent visit (2 months up to 36 months) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Form of Carbonic Anhydrase Inhibitor. Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt.
dorzolamide: 2% dorzolamide- 1 Gtt TID | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Topical Form of Carbonic Anhydrase Inhibitor. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 42 years |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)
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.
Time frame: Baseline and most recent visit (2 months up to 36 months)
Population: Intent to treat population (all participants assigned to Trusopt (2% dorzolamide).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trusopt (2% Dorzolamide) | Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT) | 36 participants |
Primary
Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)
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.
Time frame: Baseline and most recent visit (2 month up to 36 months)
Population: Intent to treat population (all participants assigned to Trusopt (2% dorzolamide).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trusopt (2% Dorzolamide) | Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT) | 36 participants |
Secondary
Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart
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.
Time frame: Baseline and most recent visit (2 months up to 36 months)
Population: Intent to treat population (all participants assigned to Trusopt (2 % dorzolamide).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trusopt (2% Dorzolamide) | Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart | 20 participants |