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

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Bausch + Lomb

Status and phase

Completed
Phase 3

Conditions

Vitreous Hemorrhage
Diabetic Retinopathy

Treatments

Drug: Vitrase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00198510
VIT-02-08961X

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

750 participants in 2 patient groups

Vitrase
Experimental group
Description:
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Treatment:
Drug: Vitrase
Drug: Vitrase
Drug: Vitrase
Observation
No Intervention group
Description:
Observation only, no medication or intravitreal injection

Trial contacts and locations

73

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Data sourced from clinicaltrials.gov

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