Contact information
Type
Scientific
Primary contact
Dr William Schiff
ORCID ID
Contact details
635 West 165th Street
New York
10032
United States of America
+1 212 305 5922
wms13@columbia.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IM-VIT 100-01 (IND # 63,756)
Study information
Scientific title
Acronym
IM-VIT100
Study hypothesis
To determine the safety and efficacy of VIT100 (VitrenAse), a proliferating cell nuclear antigen (PCNA) ribozyme (Immusol, Inc. San Diego, CA), in preventing recurrent proliferative vitreoretinopathy (PVR) in patients with established PVR who undergo vitrectomy for retinal reattachment repair.
Ethics approval
Columbia University Institutional Review Board reviewed and approved research on the 31st July 2003 (reference number: AAA8110).
Study design
Multicentre, double-masked, placebo controlled, randomised clinical trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Proliferative Vitreoretinopathy
Intervention
All patients undergo retinal reattachment surgery with pars plana vitrectomy. Additional intraoperative procedures including scleral buckle placement or revision, pars plana lensectomy or limbal cataract extraction, Intraocular Lens (IOL) implantation or removal, temporary keratoprosthesis and penetrating keratoplasty, retinotomy, and/or gas or silicone oil tamponade could be performed at the discretion of the operating surgeon and required the assistance of an anterior segment specialist in certain cases.
All patients were to be randomly assigned to one of the three treatment groups: 0.75 mg or 0.15 mg VitrenAse and placebo (ratio 1:1:1). A single intravenous administration of VitrenAse or placebo was administered after the completion of the vitrectomy procedure.
Intervention type
Drug
Phase
Not Specified
Drug names
VitrenAse (VIT100)
Primary outcome measures
Efficacy variables included:
1. Failure rate of retina repair surgery secondary to PVR
2. All cause of failure rate of retina repair surgery
3. Retinal status
Secondary outcome measures
Safety variables included:
1. ETDRS best corrected visual acuity
2. Lens status
3. Intraocular pressure
4. Biomicroscopy findings
5. Adverse effects
6. Serum Blood Urea Nitrogen (BUN) and creatinine
Overall trial start date
01/07/2002
Overall trial end date
31/08/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with retinal detachment with Grade C or worse PVR who undergo vitrectomy for retinal reattachment:
1. Retinal detachment
2. Proliferative vitreoretinopathy (PVR) grade C or worse under direct visualisation
3. Visual acuity greater than no light perception
4. Aged at least 18 years
5. Patient willing and able to sign informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170
Participant exclusion criteria
1. Vision of no light perception
2. Presence of any uncontrolled, sight threatening concomitant eye disease
3. Severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy according to Early Treatment Diabetic Retinopathy Study (ETDRS) criteria
4. Other pre-existing vaso-proliferative retinopathy
5. History of intraocular inflammatory disease
6. Retinoschisis detachment
7. Heredity vitreoretinopathies
8. Best corrected visual acuity less than 20/200 prior to onset of retinal detachment due to permanent pre-existing condition
9. Vision less than 5/200 or visual field less than 20 degrees in the fellow eye
10. Pregnant or nursing women or women of childbearing potential not using a reliable form of contraception
11. Concurrent participation in any other research study within 30 days of entry into the study
Recruitment start date
01/07/2002
Recruitment end date
31/08/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
635 West 165th Street
New York
10032
United States of America
Sponsor information
Organisation
Immusol, Inc. (USA)
Sponsor details
10790 Roselle Street
San Diego
CA
92121
United States of America
+1 858 824 1100
bsimon@immusol.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Immusol, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/17846353
Publication citations
-
Results
Schiff WM, Hwang JC, Ober MD, Olson JL, Dhrami-Gavazi E, Barile GR, Chang S, Mandava N, Safety and efficacy assessment of chimeric ribozyme to proliferating cell nuclear antigen to prevent recurrence of proliferative vitreoretinopathy., Arch. Ophthalmol., 2007, 125, 9, 1161-1167, doi: 10.1001/archopht.125.9.1161.