Macular DegenerationNCT03105609
Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
An observational study of Macular Degeneration and Choroidal Neovascularization, run by Center for Eye Research Australia at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- Hyperspectral imaging
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Nov 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 50-80 presenting for care in private ophthalmology practice with retinal specialists
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Eye Research Australia
East Melbourne, Victoria, 3002
About this study
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.
Read the 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
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Being tested
- Hyperspectral imaging
- Keywords
- hyperspectral imaging, Ranibizumab
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral imagingDevice
Also called Metabolic Hyperspectral Retinal Camera; Optina Diagnostics, Montreal, Canada
Hyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hyperspectral imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-9 months
Secondary outcomes (1)
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.
Measured: 3-9months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start14 Nov 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: The delay between diagnosis and initiation of treatment was no longer consistent with standard of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Eye Research Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Marc Sarossy, Center for Eye Research Australia
- Investigators
- Marc G Sarossy, FRANZCO, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105609
- Sponsor's protocol ID
- 16/1301H 21020
- Status last verified
- Feb 2019
- First submitted
- 28 Mar 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD not to be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
- ClinicalTrials.gov ID
- NCT03105609
- Acronym / sponsor ID
- 16/1301H 21020
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Keywords
- hyperspectral imaging, Ranibizumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The delay between diagnosis and initiation of treatment was no longer consistent with standard of care
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naive wet age-related macular degeneration | – | Device: Hyperspectral imagingPatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 50-80 presenting for care in private ophthalmology practice with retinal specialists
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperspectral imagingAlso: Metabolic Hyperspectral Retinal Camera; Optina Diagnostics, Montreal, CanadaHyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment. | Device | Naive wet age-related macular degeneration |
Primary outcome
Hyperspectral image characteristics that predict response of choroidal neovascularisation to Lucentis
Time frame: 3-9 months
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.
1 secondary outcome
Specific spectral signature for identification of exudative AMD
Time frame: 3-9months
Results and safety
The study was stopped early (reason given: The delay between diagnosis and initiation of treatment was no longer consistent with standard of care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No. IPD not to be shared
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc G Sarossy, FRANZCO principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration and Choroidal Neovascularization, run by Center for Eye Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The delay between diagnosis and initiation of treatment was no longer consistent with standard of care). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperspectral image characteristics that predict response of choroidal neovascularisation to Lucentis (time frame: 3-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.