Contact information
Type
Scientific
Primary contact
Dr K A van Overdam
ORCID ID
Contact details
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 4017777
kvoverdam@oogziekenhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OZR-2005-14
Study information
Scientific title
Acronym
CRVO study
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised conventional therapy controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Recombinant tissue Plasminogen Activator (rt-PA)
Primary outcome measures
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 trial start date
01/07/2006
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
Sponsor information
Organisation
Oogziekenhuis Rotterdam (OZR) (The Netherlands)
Sponsor details
P.O. Box 70030
Rotterdam
3000 LM
Netherlands
+31 (0)10 4017777
info@oogziekenhuis.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)
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