A safety and efficacy assessment of chimeric ribozyme to proliferating cell nuclear antigen to prevent recurrence of proliferative vitreoretinopathy
| ISRCTN | ISRCTN25825250 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25825250 |
| Secondary identifying numbers | IM-VIT 100-01 (IND # 63,756) |
- Submission date
- 23/08/2006
- Registration date
- 13/09/2006
- Last edited
- 19/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr William Schiff
Scientific
Scientific
635 West 165th Street
New York
10032
United States of America
| Phone | +1 212 305 5922 |
|---|---|
| wms13@columbia.edu |
Study information
| Study design | Multicentre, double-masked, placebo controlled, randomised clinical trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study acronym | IM-VIT100 |
| Study objectives | 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(s) | Columbia University Institutional Review Board reviewed and approved research on the 31st July 2003 (reference number: AAA8110). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | VitrenAse (VIT100) |
| Primary outcome measure | 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 study start date | 01/07/2002 |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 170 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- United States of America
Study participating centre
635 West 165th Street
New York
10032
United States of America
10032
United States of America
Sponsor information
Immusol, Inc. (USA)
Industry
Industry
10790 Roselle Street
San Diego, CA
92121
United States of America
| Phone | +1 858 824 1100 |
|---|---|
| bsimon@immusol.com | |
| Website | http://www.immusol.com |
"ROR" |
https://ror.org/03q43d318 |
Funders
Funder type
Industry
Immusol, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |
