Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trusopt (2% dorzolamide) Intent to treat population. All participants assigned to Trusopt (2% dorzolamide) |
Drug: 2% dorzolamide
Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Presence of cystic macular fluid on OCT testing
Exclusion Criteria:
-
Allergic reaction to sulpha containing compounds
-
Intolerance to dorzolamide (Trusopt)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois Medical Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Gerald A Fishman, MD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2005-0551
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Trusopt (2 % Dorzolamide). |
|---|---|
| Arm/Group Description | Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day. |
| Period Title: Overall Study | |
| STARTED | 44 |
| COMPLETED | 44 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Topical Form of Carbonic Anhydrase Inhibitor. |
|---|---|
| Arm/Group Description | Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt. dorzolamide: 2% dorzolamide- 1 Gtt TID |
| Overall Participants | 44 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
43
97.7%
|
| >=65 years |
1
2.3%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
42
|
| Sex: Female, Male (Count of Participants) | |
| Female |
15
34.1%
|
| Male |
29
65.9%
|
| Region of Enrollment (Count of Participants) | |
| United States |
44
100%
|
Outcome Measures
| Title | Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population (all participants assigned to Trusopt (2% dorzolamide). |
| Arm/Group Title | Trusopt (2% Dorzolamide) |
|---|---|
| Arm/Group Description | Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day |
| Measure Participants | 44 |
| Number [participants] |
36
81.8%
|
| Title | Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population (all participants assigned to Trusopt (2% dorzolamide). |
| Arm/Group Title | Trusopt (2% Dorzolamide) |
|---|---|
| Arm/Group Description | Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide ), 1 drop three times per day. |
| Measure Participants | 44 |
| Number [participants] |
36
81.8%
|
| Title | Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population (all participants assigned to Trusopt (2 % dorzolamide). |
| Arm/Group Title | Trusopt (2% Dorzolamide) |
|---|---|
| Arm/Group Description | Topical form of carbonic anhydrase inhibitor, Trusopt (2% dorzolamide), 1 drop three times per day |
| Measure Participants | 44 |
| Number [participants] |
20
45.5%
|
Adverse Events
| Time Frame | Adverse event data will be collected during participant study participation, up to 36 months. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Topical Form of Carbonic Anhydrase Inhibitor | |
| Arm/Group Description | Participants 18 years or older with cystoid macular edema and retinal degeneration will be treated with Trusopt. dorzolamide: 2% dorzolamide- 1 Gtt TID | |
All Cause Mortality |
||
| Topical Form of Carbonic Anhydrase Inhibitor | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/44 (0%) | |
Serious Adverse Events |
||
| Topical Form of Carbonic Anhydrase Inhibitor | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/44 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Topical Form of Carbonic Anhydrase Inhibitor | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/44 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Emeritus Professor of Ophthalmology |
|---|---|
| Organization | University of Illinois at Chicago |
| Phone | 312 997-3646 |
| gerafish@uic.edu |
- 2005-0551