Recombinant tissue Plasminogen Activator administration by retinal branch vein route for Central Retinal Vein Occlusion: a randomised conventional therapy controlled trial
| ISRCTN | ISRCTN58543190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58543190 |
| Secondary identifying numbers | OZR-2005-14, NL646 (NTR707) |
- Submission date
- 26/09/2006
- Registration date
- 26/09/2006
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K A van Overdam
Scientific
Scientific
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
| Phone | +31 (0)10 4017777 |
|---|---|
| kvoverdam@oogziekenhuis.nl |
Study information
| Study design | Randomised conventional therapy controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Recombinant tissue Plasminogen Activator administration by retinal branch vein route for Central Retinal Vein Occlusion: a randomised conventional therapy controlled trial |
| Study acronym | CRVO study |
| Study objectives | Recombinant tissue Plasminogen Activator (rt-PA) administration by retinal branch vein way in Central Retinal Vein Occlusion (CRVO) patients improves final Best Corrected Visual Acuity (BCVA). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Central Retinal Vein Occlusion (CRVO) |
| Intervention | Injection of rt-PA (0.2 mg/ml, 4 ml) in retinal branch vein. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Recombinant tissue Plasminogen Activator (rt-PA) |
| Primary outcome measure | BCVA on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. |
| Secondary outcome measures | Reduction in: 1. Neovascular changes 2. Neovascular glaucoma 3. Rates of development of macular oedema |
| Overall study start date | 01/07/2006 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 |
| Key inclusion criteria | 1. Informed consent 2. Over 18 years of age 3. Adequate birth control (if not post-menopausal or sterilised) during a two week pre- and six week post-operative period if assigned to vitreoretinal surgery 4. Subjective decrease in visual acuity starting within four weeks prior to study start, due to CRVO, clinically evident by fundoscopy 5. Non-perfused or perfused CRVO with a visual acuity of less than 20/200 Note : Pseudophakic patients are allowed to participate in this study. |
| Key exclusion criteria | 1. Inability to visualize fundus due to corneal or important lenticular opacities 2. Inability to obtain photographs of CRVO due to allergy to fluorescein or lack of veinous access 3. As visual acuity prognosis is better and risk for neovascularisation is reduced in perfused CRVO, patients with a visual acuity of more than 20/200 will not be included 4. Presence of iris neovascularisation (more than grade one) or anterior chamber angle (more than grade one) at the moment of presentation 5. Other retinal or ophthalmic disorders that could influence the macular area 6. Disorders that could be complicated by iris or retinal neovascularisation 7. Disorders that could be complicated by any form of secondary glaucoma 8. Prescription of acetazolamide or high dose systemic steroid (more than 10 mg prednisone daily) or other anti-inflammatory medication (eg. Methotrexate (MTX), Imuran, Endoxan, Humira, Kineret, Infliximab, Thalidomide) except Non Steriodal Anti-Inflammatory Drugs (NSAIDs) 9. Participation in another clinical ophthalmic trial 10. Any surgery of the orbit, ocular adnexae or eye scheduled during the period the study (except for cataract surgery, developed after inclusion to a degree as outlined by the protocol) 11. Monophthalmia or other known ophthalmic disorder in the fellow eye that could be complicated by blindness 12. Previous retinal surgery 13. High myopia (-8 D spherical equivalent or more) 14. Macula affecting drugs |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
3011 BH
Netherlands
Sponsor information
Oogziekenhuis Rotterdam (OZR) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 70030
Rotterdam
3000 LM
Netherlands
| Phone | +31 (0)10 4017777 |
|---|---|
| info@oogziekenhuis.nl | |
"ROR" |
https://ror.org/02hjc7j46 |
Funders
Funder type
Research organisation
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)
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 |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
