Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
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ClinicalTrials.gov Identifier: NCT00198510 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2013
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Condition or disease | Intervention/treatment | Phase |
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Vitreous Hemorrhage Diabetic Retinopathy | Drug: Vitrase | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 750 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage |
Study Start Date : | November 1998 |
Actual Primary Completion Date : | September 2001 |
Actual Study Completion Date : | March 2003 |
Arm | Intervention/treatment |
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Experimental: Vitrase
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
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Drug: Vitrase
7.5 IU of Vitrase
Other Name: ovine hyaluronidase Drug: Vitrase 55 IU of Vitrase
Other Name: ovine hyaluronidase Drug: Vitrase 75 IU of Vitrase
Other Name: ovine hyaluronidase |
No Intervention: Observation
Observation only, no medication or intravitreal injection
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- Resolution of Vitreous Hemorrhage [ Time Frame: 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
- Incidence of complications & adverse events [ Time Frame: 12 months ]
- Visual Acuity [ Time Frame: 3 months, 6 months, 12 months ]Best correct visual acuity (BCVA)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198510

Study Director: | Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00198510 |
Other Study ID Numbers: |
VIT-02-08961X |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | March 15, 2013 |
Last Verified: | March 2013 |
Diabetic Retinopathy Vitreous Hemorrhage Hemorrhage Pathologic Processes Retinal Diseases Eye Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Eye Hemorrhage |