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ISRCTN
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ISRCTN58543190
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ClinicalTrials.gov identifier
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Public title
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Recombinant tissue Plasminogen Activator administration by retinal branch vein route for Central Retinal Vein Occlusion: a randomised conventional therapy controlled trial
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Scientific title
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Acronym
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CRVO study
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Serial number at source
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OZR-2005-14
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Study hypothesis
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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).
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised conventional therapy controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Central Retinal Vein Occlusion (CRVO)
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2006
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Anticipated end date
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30/06/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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48
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Interventions
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Injection of rt-PA (0.2 mg/ml, 4 ml) in retinal branch vein.
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Primary outcome measure(s)
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BCVA on Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
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Secondary outcome measure(s)
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Reduction in:
1. Neovascular changes
2. Neovascular glaucoma
3. Rates of development of macular oedema
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Sources of funding
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Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
K A
van Overdam
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Address
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Oogziekenhuis Rotterdam
Schiedamsevest 180
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City/town
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Rotterdam
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Zip/Postcode
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3011 BH
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Country
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Netherlands
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Tel
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+31 (0)10 4017777
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Fax
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+31 (0)10 4017655
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Email
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kvoverdam@oogziekenhuis.nl
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Sponsor
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Oogziekenhuis Rotterdam (OZR) (The Netherlands)
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Address
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P.O. Box 70030
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City/town
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Rotterdam
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Zip/Postcode
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3000 LM
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Country
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Netherlands
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Tel
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+31 (0)10 4017777
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Email
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info@oogziekenhuis.nl
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Date applied
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26/09/2006
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Last edited
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11/05/2007
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Date ISRCTN assigned
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26/09/2006
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