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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03105609




Registration number
NCT03105609
Ethics application status
Date submitted
28/03/2017
Date registered
10/04/2017
Date last updated
5/02/2019

Titles & IDs
Public title
Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
Scientific title
Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
Secondary ID [1] 0 0
16/1301H 21020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration 0 0
Choroidal Neovascularization 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Hyperspectral imaging

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.


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3-9 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
3-9months

Eligibility
Key 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
Minimum age
50 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03105609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc G Sarossy, FRANZCO
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03105609