Eye Diseases, Pseudovitellium Detachment
Conditions
Brief summary
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment.
Interventions
Sponsors
Alcon Research
Manhattan Eye, Ear & Throat Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of patients with pseudovitellium detachment. 2. Patients must be at least 18 years of age. 3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart 4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart
Exclusion criteria
1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. 2. Patients who have undergone intraocular surgery within the last 2 months. 3. Patient participating in any other investigational drug study. 4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. 5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access). 6. Patient with significant liver disease or uremia. 7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine. 8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study 9. Patient has had insertion of scleral buckle in the study eye 10. Patient has received radiation treatment 11. Patient is on anticoagulant therapy with the exception of aspirin 12. Patient is pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg) | 24 months |
Countries
United States
Outcome results
None listed