A safety and efficacy assessment of chimeric ribozyme to proliferating cell nuclear antigen to prevent recurrence of proliferative vitreoretinopathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN25825250

Enrollment

170

Registered

2006-09-13

Start date

2002-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Vitreoretinopathy Eye Diseases Proliferative Vitreoretinopathy

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 catar

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026