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The delay between diagnosis and initiation of treatment was no longer consistent with standard of care
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naive wet age-related macular degeneration | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperspectral imaging | Device | Hyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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Patients aged 50-80 presenting for care in private ophthalmology practice with retinal specialists
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| Name | Affiliation | Role |
|---|---|---|
| Marc G Sarossy, FRANZCO | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Eye Research Australia | East Melbourne | Victoria | 3002 | Australia |
IPD not to be shared
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| ID | Term |
|---|---|
| D000081862 | Hyperspectral Imaging |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |