Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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

Study type
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

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

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

- 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
Both males and females
Can healthy volunteers participate?
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
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Center for Eye Research Australia
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

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
Trial related presentations / publications
Public notes

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