Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Vitreous Hemorrhage; Diabetic Retinopathy

Treatments: Drug: Vitrase; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00198497

VIT-03-08961X

Details and patient eligibility

About

The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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510 participants in 2 patient groups, including a placebo group

Vitrase

Experimental group

Description:

Single Hyaluronidase ophthalmic intravitreal injection

Treatment:

Drug: Vitrase

Drug: Vitrase

Placebo

Placebo Comparator group

Description:

Single Saline solution intravitreal injection

Treatment:

Drug: Placebo