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

NCT03105609 | Terminated

• 1 other identifier: 16/1301H 21020
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration; Choroidal Neovascularization

Keywords

hyperspectral imaging, Ranibizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specific spectral signature for identification of exudative AMD

  3-9months

Study Arms (1)

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.

Device: Hyperspectral imaging

Interventions

Hyperspectral imaging DEVICE

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

Also known as: Metabolic Hyperspectral Retinal Camera; Optina Diagnostics, Montreal, Canada

Naive wet age-related macular degeneration

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 50-80 presenting for care in private ophthalmology practice with retinal specialists

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Eye Research Australia: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Hyperspectral Imaging

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Marc G Sarossy, FRANZCO

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 10, 2017
• Study Start: November 14, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)