Condition category
Eye Diseases
Date applied
23/08/2006
Date assigned
13/09/2006
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.immusol.com/

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

http://www.immusol.com

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

  1. 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.

Additional files

Editorial Notes