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
Protocol serial number	OZR-2005-14, NL646 (NTR707)
Sponsor	Oogziekenhuis Rotterdam (OZR) (The Netherlands)
Funder	Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)

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

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Phone	+31 (0)10 4017777
Email	kvoverdam@oogziekenhuis.nl

Study information

Primary study design	Interventional
Study design	Randomised conventional therapy controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Recombinant tissue Plasminogen Activator (rt-PA)
Primary outcome measure(s)	BCVA on Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Key secondary outcome measure(s)	Reduction in: 1. Neovascular changes 2. Neovascular glaucoma 3. Rates of development of macular oedema
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.