Not provided
Not provided
Not provided
Not provided
Not provided
Preliminary data analysis showed insufficient efficacy to justify continuation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg anecortave acetate | Active Comparator |
| |
| 15 mg anecortave acetate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anecortave acetate | Drug | anterior juxtascleral depot of 15 mg anecortave acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Within Normal Limits (<24 mm Hg) | Intraocular pressure was measured by Goldmann applanation tonometry. | 1 month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francis W. Price, Jr., MD | Cornea Research Foundation of America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 30 mg Anecortave Acetate | |
| FG001 | 15 mg Anecortave Acetate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 30 mg Anecortave Acetate | |
| BG001 | 15 mg Anecortave Acetate | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Intraocular Pressure Within Normal Limits (<24 mm Hg) | Intraocular pressure was measured by Goldmann applanation tonometry. | Per protocol | Posted | Number | Participants | 1 month |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30 mg Anecortave Acetate |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure elevation | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Price, PhD | Cornea Research Foundation of America | 317-814-2990 | mprice@cornea.org |
Not provided
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C418047 | anecortave acetate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 mg anecortave acetate | Drug | anterior juxtascleral depot of 30mg anecortave acetate |
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 5 |
| 4 |
| 5 |
| EG001 | 15 mg Anecortave Acetate | 0 | 2 | 2 | 2 |
| Eye discomfort | Eye disorders | Systematic Assessment |
|
| Cornea transplant rejection episode | Eye disorders | Systematic Assessment |
|
Not provided
Not provided