Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACRVOS
Study information
Scientific title
Acronym
ACRVOS (Atorvastatin for CRVO Study)
Study hypothesis
It has been suggested that in some instances an atherosclerotic central retinal artery impinges on the central vein, causing turbulence, endothelial damage and thrombus formation. Atorvastatin, with its lipid lowering action, may help in reducing the impingement on central retinal vein and therefore help in restoring the normal blood flow. Apart from the primary hypothesis, the protective role on endothelium may also be a determining factor for the final visual outcome.
Ethics approval
Ethics approval was not applied for since we don't have such a body here in India. Also, since the drug we plan to try is being prescribed for various other pathologies, this is just another indication which we might come up with.
This particular trial is the first one of the use of this drug for the given problem. There has not even been a case report of the drug use for CRVO. Since we have deeply studied the pathology of the disease and the action of the drug, we are expecting a positive response.
The patients will be fully informed of the nature of the treatment and only after consent will the drug be used.
Study design
Randomised 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
Intervention
Intervention treatment:
Duration of atorvastatin planned to be given is for two months. Dosage is to be 10 mg per day, given once in a day, orally.
Control treatment:
Treatment as usual.
Both groups will be subject to Laser pan-retinal photocoagulation and regular protocol in case of any complications arising from CRVO.
Follow up will be for every third/fourth day upto a maximum of 15 days from the date of incident and then once every week for a period of month. A late follow up is planned at six months from the incident of CRVO and at one year.
Patients who report to us within 24 hours of CRVO will receive the regular care and treatment so as to release/dissolve the clot and restore normal flow and such cases will obviously be not included in any group. Since this treatment is usually not effective after a few hours, we have planned our study for cases presenting at a late stage and for long term prognosis.
Intervention type
Drug
Phase
Not Specified
Drug names
Atorvastatin
Primary outcome measures
1. Visual acuity
2. Tortuosity of retinal veins
Secondary outcome measures
Recurrence of Central Retinal Vein Occlusion
Overall trial start date
10/05/2007
Overall trial end date
09/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with:
1. Central Retinal Vein Occlusion (CRVO) of more than one day duration
2. No other ophthalmic pathologies
3. No contraindication to atorvastatin
4. No prior use of statins
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
Patients with CRVO of less than one day duration are treated conventionally and those who have other ophthalmic pathologies or patients who have been on atorvastatin or any other statins earlier are not included in any groups.
Recruitment start date
10/05/2007
Recruitment end date
09/05/2009
Locations
Countries of recruitment
India
Trial participating centre
3/198 Vishnupuri
Kanpur
208002
India
Sponsor information
Organisation
J L Rohatgi Eye Hospital (India)
Sponsor details
Sarvodaya Nagar
Kanpur
208002
India
jlrhospital@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
J L Rohatgi Memorial Eye Hospital (India) and investigator funded trial
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