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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trusopt (2% dorzolamide) | Experimental | Intent to treat population. All participants assigned to Trusopt (2% dorzolamide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% dorzolamide | Drug | Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and most recent visit (2 month up to 36 months) |
| 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. | Baseline and most recent visit (2 months up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald A Fishman, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18834580 | Derived | Walia S, Fishman GA, Molday RS, Dyka FM, Kumar NM, Ehlinger MA, Stone EM. Relation of response to treatment with dorzolamide in X-linked retinoschisis to the mechanism of functional loss in retinoschisin. Am J Ophthalmol. 2009 Jan;147(1):111-115.e1. doi: 10.1016/j.ajo.2008.07.041. Epub 2008 Oct 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trusopt (2 % Dorzolamide). | Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants will initially be seen by Dr. Fishman and have their foveal thickness, macular fluid and vision measured. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat population (all participants assigned to Trusopt (2% dorzolamide). | Posted | Number | participants | Baseline and most recent visit (2 month up to 36 months) |
|
Adverse event data will be collected during participant study participation, up to 36 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emeritus Professor of Ophthalmology | University of Illinois at Chicago | 312 997-3646 | gerafish@uic.edu |
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| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| C062765 | dorzolamide |
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| Baseline and most recent visit (2 months up to 36 months) |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| 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. | Intent to treat population (all participants assigned to Trusopt (2% dorzolamide). | Posted | Number | participants | Baseline and most recent visit (2 months up to 36 months) |
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| 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. | Intent to treat population (all participants assigned to Trusopt (2 % dorzolamide). | Posted | Number | participants | Baseline and most recent visit (2 months up to 36 months) |
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