Condition category
Eye Diseases
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
11/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes