| Registry | NCT03105609 |
|---|---|
| Status | Terminated - The delay between diagnosis and initiation of treatment was no longer consistent with standard of care |
| Study type | Observational |
| Enrollment | 4 (Actual) |
| Sponsor | Center for Eye Research Australia (Other); collaborators: Novartis Pharmaceuticals |
| Conditions | Macular Degeneration, Choroidal Neovascularization |
| Interventions | Hyperspectral imaging (Device) |
| Dates | start 2017-11-14, primary completion 2018-12-01, completion 2018-12-01, first posted 2017-04-10, last updated 2019-02-05 |
| Locations | 1 site in Australia |
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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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Naive wet age-related macular degeneration | Device: Hyperspectral imaging | 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. |
Sex: All, ages: 50 Years to 80 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Centre for Eye Research Australia | East Melbourne, Victoria | Australia |