Study Stopped
slow enrollment , interim analysis conducted.
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects
1 other identifier
interventional
400
2 countries
17
Brief Summary
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedOctober 20, 2009
October 1, 2009
1.8 years
April 18, 2008
October 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ultrasound
7 Months
Secondary Outcomes (1)
Ultrasound, OCT, Safety
7 Months
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects with a history of systemic diabetes (type I or II)
- Subject with a documented history of Non Proliferative Diabetic Retinopathy (NPDR)
- Subjects with no PVD at baseline exam in the study eye.
You may not qualify if:
- Subjects with Retinal pathology in the study eye other than (NPDR)
- Subjects with high myopia in the study eye
- Subjects who have monocular vision or contra lateral vision of 20/200 or worse BCVA in the non-study eye.
- Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
- Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Lakeland, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
New Albany, Indiana, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
McAllen, Texas, United States
Unknown Facility
Silverdale, Washington, United States
LVPEI
Bhubhneshwar, India
Sankara Nethralaya
Chennai, India
Aravind
Coimbatore, India
AIIMS
Delhi, India
LVPEI
Hyderabad, India
Aravind
Madurai, India
Aravind
Puducherry, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baruch Kupperman, MD
University of California, Irvine
- PRINCIPAL INVESTIGATOR
Naresh Mandova, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 22, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Last Updated
October 20, 2009
Record last verified: 2009-10