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

NCT ID: NCT03105609

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2018-12-01

Brief Summary

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

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

Conditions

Macular Degeneration; Choroidal Neovascularization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Hyperspectral imaging

Intervention Type: DEVICE

Hyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment.

Interventions

Hyperspectral imaging

Hyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment.

Intervention Type: DEVICE

Other Intervention Names

Metabolic Hyperspectral Retinal Camera; Optina Diagnostics, Montreal, Canada

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Center for Eye Research Australia

OTHER

Sponsor Role: lead

Responsible Party

Marc Sarossy

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc G Sarossy, FRANZCO

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Centre for Eye Research Australia

East Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

16/1301H 21020

Identifier Type: -

Identifier Source: org_study_id