Diabetic Retinopathy, Vitreous Hemorrhage
Conditions
Brief summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Interventions
DRUGPlacebo
DRUGVitrase
Hyaluronidase 55 IU in saline solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present \>/= 1 month by history or exam * BCVA is worse than 20/200 at time of screening
Exclusion criteria
* Corneal or lenticular abnormalities that preclude fundus observation * Ongoing ocular infection, inflammation or history of herpetic corneal lesion * Current or prior retinal detachment or retinal tears or breaks or intraocular tumor * More than 1 severe vitreous hemorrhage within 6 months * Previous vitrectomy for any reason * Hemorrhage is exclusively pre-retinal, or old & organized * Prior Vitrase for intravitreal injection in either eye * No light perception in either eye at any time * Known contraindications to study medication * Sickle cell disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitreous hemorrhage resolution | 3 months | laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula & at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 12 months |
| Visual Acuity | 3 months, 6 months and 12 months |
Countries
Australia, Brazil, Hungary, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom
Outcome results
None listed