Clinical trial NCT03105609: Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
Official title: Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Macular Degeneration
Choroidal Neovascularization
Keywords: hyperspectral imaging, Ranibizumab
Lead sponsor: Center for Eye Research Australia
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2017-04-10
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 50-80 presenting for care in private ophthalmology practice with retinal specialists

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

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.

Primary outcomes:
measure: Hyperspectral image characteristics that predict response of choroidal neovascularisation to Lucentis
timeFrame: 3-9 months
Secondary outcomes:
measure: Specific spectral signature for identification of exudative AMD
timeFrame: 3-9months
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
Study officials:
affiliation: Principal Investigator
name: Marc G Sarossy, FRANZCO
role: PRINCIPAL_INVESTIGATOR
References: