Macular Degeneration Clinical Trial
Official title:
Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
Verified date | February 2019 |
Source | Center for Eye Research Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Clinical trial investigating the role of hyperspectral imaging in the management of patients undergoing standard clinical treatment for naive neovascular choroidal membranes in age-related macular degeneration.
Status | Terminated |
Enrollment | 4 |
Est. completion date | December 1, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Provide signed and dated informed consent form - Willing to comply with all study procedures and be available for the duration of the study - Male or female, aged 50-80 - In sufficiently good general health to be able to have a FFA - CNV diagnosed by OCT - Vision equal or better than 6/60 in the study eye - No prior treatment in the study eye with anti-VEGF medication Exclusion Criteria - Significant media opacity. - Known allergic reactions to components of the study product(s). - Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. |
Country | Name | City | State |
---|---|---|---|
Australia | Centre for Eye Research Australia | East Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Center for Eye Research Australia | Novartis Pharmaceuticals |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hyperspectral image characteristics that predict response of choroidal neovascularisation to Lucentis | Hyperspectral images will be analysed to define specific characteristics that identify which types of choroidal neovascularisation will respond to Lucentis. Responsive patients will be differentiated from non-responders and distinguishing image features will be identified. | 3-9 months | |
Secondary | Specific spectral signature for identification of exudative AMD | Spectral bands of the HSI containing the most predictive information for diagnosis and treatment response will be characterised. | 3-9months |
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