|
Welcome
|
|
28 August 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| A safety and efficacy assessment of chimeric ribozyme to proliferating cell nuclear antigen to prevent recurrence of proliferative vitreoretinopathy |
| ISRCTN | ISRCTN25825250 |
| ClinicalTrials.gov identifier | |
| Public title | A safety and efficacy assessment of chimeric ribozyme to proliferating cell nuclear antigen to prevent recurrence of proliferative vitreoretinopathy |
| Scientific title | |
| Acronym | IM-VIT100 |
| Serial number at source | IM-VIT 100-01 (IND # 63,756) |
| 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. |
| Countries of recruitment | United States of America |
| Disease/condition/study domain | Proliferative Vitreoretinopathy |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/07/2002 |
| Anticipated end date | 31/08/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 170 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Immusol, Inc. (USA) |
| Trial website | http://www.immusol.com/ |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/17846353 |
| Contact name | Dr William Schiff |
| Address | 635 West 165th Street |
| City/town | New York |
| Zip/Postcode | 10032 |
| Country | United States of America |
| Tel | +1 212 305 5922 |
| Fax | +1 212 305 0900 |
| wms13@columbia.edu | |
| Sponsor | Immusol, Inc. (USA) |
| Address | 10790 Roselle Street |
| City/town | San Diego, CA |
| Zip/Postcode | 92121 |
| Country | United States of America |
| Tel | +1 858 824 1100 |
| Fax | +1 858 824 1112 |
| bsimon@immusol.com | |
| Sponsor website: | http://www.immusol.com |
| Date applied | 23/08/2006 |
| Last edited | 19/02/2008 |
| Date ISRCTN assigned | 13/09/2006 |
|
|
|
| © ISRCTN | |
|
|
|
|