Intraocular Pressure, Transplant
Conditions
Keywords
cornea, transplant, intraocular pressure, steroid response
Brief summary
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.
Interventions
anterior juxtascleral depot of 15 mg anecortave acetate
DRUG30 mg anecortave acetate
anterior juxtascleral depot of 30mg anecortave acetate
Sponsors
Cornea Research Foundation of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline
Exclusion criteria
* not pregnant or lactating * intraocular surgery in the study eye within 30 days before enrolling in the study * use of any investigational drug or treatment within 30 days before receipt of study medication * clinical evidence of scleral thinning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure Within Normal Limits (<24 mm Hg) | 1 month | Intraocular pressure was measured by Goldmann applanation tonometry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 30 mg Anecortave Acetate | 5 |
| 15 mg Anecortave Acetate | 2 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 15 mg Anecortave Acetate | 30 mg Anecortave Acetate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 2 | 64 years STANDARD_DEVIATION 19 | 65 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 2 participants | 5 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 5 | 2 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 |
Outcome results
Primary
Intraocular Pressure Within Normal Limits (<24 mm Hg)
Intraocular pressure was measured by Goldmann applanation tonometry.
Time frame: 1 month
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 30 mg Anecortave Acetate | Intraocular Pressure Within Normal Limits (<24 mm Hg) | 2 Participants |
| 15 mg Anecortave Acetate | Intraocular Pressure Within Normal Limits (<24 mm Hg) | 1 Participants |
p-value: 0.57Fisher Exact