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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03105609
• Other study ID #: 16/1301H 21020
• Status: Terminated
• Start date: November 14, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2019
• Source: Center for Eye Research Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic
• Retinal Neovascularization

Intervention

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

Locations

Country	Name	City	State
Australia	Centre for Eye Research Australia	East Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Center for Eye Research Australia	Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3-9months