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Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198510
First received: September 13, 2005
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
| Condition | Intervention | Phase |
|---|---|---|
| Vitreous Hemorrhage Diabetic Retinopathy | Drug: Vitrase | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bleeding
Drug Information available for:
Hyaluronidase
U.S. FDA Resources
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Incidence of complications & adverse events [ Time Frame: 12 months ]
- Visual Acuity [ Time Frame: 3 months, 6 months, 12 months ]Best correct visual acuity (BCVA)
| Estimated Enrollment: | 750 |
| Study Start Date: | November 1998 |
| Study Completion Date: | March 2003 |
| Primary Completion Date: | September 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitrase
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00198510
Show 73 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198510
Show 73 Study Locations
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00198510 History of Changes |
| Other Study ID Numbers: |
VIT-02-08961X |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 14, 2013 |
Additional relevant MeSH terms:
|
Hemorrhage Diabetic Retinopathy Vitreous Hemorrhage Pathologic Processes Retinal Diseases Eye Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Eye Hemorrhage |
ClinicalTrials.gov processed this record on June 22, 2017