Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000575437
Ethics application status
Not yet submitted
Date submitted
7/11/2007
Date registered
9/11/2007
Date last updated
9/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Fellow Eye Effect with Ranibizumab for Age Related Macular Degeneration
Scientific title
In patients with wet Age Related Macular Degeneration, is ranibizumab intravitreal injection effective in improving visual acuity in the fellow eye?
Universal Trial Number (UTN)
Trial acronym
FERMAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration (wet type, characterised by choroidal neovascularisation) 2530 0
Condition category
Condition code
Eye 2630 2630 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation post-injection by Visual Acuity (VA) measurement and Optical Coherence Tomography (OCT). Patients will be observed on 6 occassions over 3 months from their initial treatment. Visual Acuity will be tested using a standard logMAR eye chart, and retinal OCT will be performed using a Copernicus Spectral OCT scanner.
Intervention code [1] 2263 0
Not applicable
Comparator / control treatment
This trial is uncontrolled, due to ethical concerns in witholding vision preserving treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3540 0
Improvement in Visual Acuity, as measured by a gain in letters on logMAR chart. 5 letters will be considered clinically significant.
Timepoint [1] 3540 0
1day, 3 days, 1 week, 2 weeks, 1 month, 3 months.
Primary outcome [2] 3541 0
Reduction in macular thickness, as measured by OCT.
Timepoint [2] 3541 0
1day, 3 days, 1 week, 2 weeks, 1 month, 3 months.
Secondary outcome [1] 5923 0
Reduction in volume of sub-retinal fluid, measured with OCT.
Timepoint [1] 5923 0
1day, 3 days, 1 week, 2 weeks, 1 month, 3 months.
Secondary outcome [2] 5924 0
Improvement in Visual Acuity of treated eye.
Timepoint [2] 5924 0
1day, 3 days, 1 week, 2 weeks, 1 month, 3 months.
Secondary outcome [3] 5925 0
Reduction of macular thickness in treated eye.
Timepoint [3] 5925 0
1day, 3 days, 1 week, 2 weeks, 1 month, 3 months.
Secondary outcome [4] 5926 0
Reduction of macular thickness in treated eye.
Timepoint [4] 5926 0
1day, 3 days, 1 week, 2 weeks, 1 month, 3 months.

Eligibility
Key inclusion criteria
• ARMD with choroidal neovascularisation in both eyes
• Involvement of the foveal centre
• Age 50 years or more
• Visual Acuity (best corrected) of 6/12 or worse in both eyes (equivalent to >0.3 logMAR)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Lesion size greater than 12 optic disc areas
• Previous anti Vascular Endothelial Growth Factor (anti-VEGF) therapy
• Contraindication for ranibizumab treatment
o Hypersensitivity to ranibizumab
o Active or suspected ocular/periocular infection
o Active intraocular inflammation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 485 0
3550

Funding & Sponsors
Funding source category [1] 2770 0
Self funded/Unfunded
Name [1] 2770 0
Country [1] 2770 0
Primary sponsor type
University
Name
Monash University
Address
Monash University
Victoria 3800
Country
Australia
Secondary sponsor category [1] 2503 0
Hospital
Name [1] 2503 0
Bendigo Health Care Group
Address [1] 2503 0
P.O. Box 126
Bendigo
Vic 3552
Country [1] 2503 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4692 0
Ethics committee address [1] 4692 0
Ethics committee country [1] 4692 0
Date submitted for ethics approval [1] 4692 0
09/11/2007
Approval date [1] 4692 0
Ethics approval number [1] 4692 0

Summary
Brief summary
Studying the Fellow Eye Effect of ranibizumab (Lucentis) injections for macular degeneration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28166 0
Address 28166 0
Country 28166 0
Phone 28166 0
Fax 28166 0
Email 28166 0
Contact person for public queries
Name 11323 0
Michael Jamieson
Address 11323 0
144 Arnold St
Bendigo 2550
Country 11323 0
Australia
Phone 11323 0
(03) 5441 1622
Fax 11323 0
Email 11323 0
[email protected]
Contact person for scientific queries
Name 2251 0
Michael Jamieson
Address 2251 0
144 Arnold St
Bendigo 2550
Country 2251 0
Australia
Phone 2251 0
(03) 5441 1622
Fax 2251 0
Email 2251 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.