Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging

Study Overview
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Brief Summary
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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.

Detailed Description
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Observational trial of patients with choroidal neovascular membranes treated with Lucentis. Exploration and validation of a new form of retinal imaging called hyperspectral imaging. Inclusion: Patients meet eligibility criteria other than FFA diagnosis and who are diagnosed with suspected exudative CNV on the OCT. (n=100 eyes) Procedure: Monthly doses of Lucentis. OCT scans will be taken prior to each injection. HSI image taken at baseline and at the 9-month time point. Time frame: 6 months recruitment + 12 months follow-up + 6 months analysis. All recruited patients will receive monthly doses of Lucentis as per the CMBS-approved protocol to allow comparison with other published studies. Lucentis will be administered in accordance with published standards of practice. OCT scans will be taken prior to each injection. HSI image will be taken at baseline, three months and 9-month time points

Official Title
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Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging

Conditions
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Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
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* Device: Hyperspectral imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Naive wet age-related macular degeneration<br>Patients recruited to the study will be patients who meet the Australian MBS criteria for treatment of exudative CNV with Lucentis. For the duration of the study, the patients will have standard induction and monthly dosing of Lucentis (Ranibizumab; intravitreal; 0.5 mg) to allow comparison with published studies. The only extra intervention for the study is the acquisition of hyperspectral mages with the hyperspectral camera and the acquisition of additional fundus autofluorescence images to the clinical norm. | Device: Hyperspectral imaging<br>* Hyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment.<br>* Other names: Metabolic Hyperspectral Retinal Camera; Optina Diagnostics, Montreal, Canada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperspectral imaging, Ranibizumab