Choroidal Neo-Vascular Age-onset Macular DegenerationPhase 2NCT00857259
The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
A Phase 2 study testing Everolimus and Ranibizumab in people with Choroidal Neo-Vascular Age-onset Macular Degeneration and Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 12 sites in 2 countries.
Trial summary
The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroidal Neo-Vascular Age-onset Macular Degeneration, Age-related Macular Degeneration
- What is being tested?
- Everolimus and Ranibizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Feb 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neovascular Age-Related Macular Degeneration (AMD)
- Best corrected visual acuity ( BCVA) of 20/40 or worse in study eye
- Patients with predominantly classic, minimally classic, or occult choroidal neovascularization in the macula of one eye (the study eye) who have had an inadequate response to VEGF inhibitors in the study eye. Inadequate response is defined as a gain of less than one line of visual acuity and persistent macular edema (central sub-fiel thickness ≥ 300 μm as measured by Optical Coherence Tomography (OCT) despite a minimum of 3 treatments with Lucentis or Avastin
Who cannot join
- Any concurrent ocular condition in the study eye that may result in substantial change in vision during the study
- Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke
- Patients who have macular edema in the study eye that, in the judgment of the investigator, is unlikely to respond to treatment. Examples of features that may guide the investigator's judgment about unresponsiveness are large regions of geographic atrophy, retinal angiomatous proliferation, or large regions of sub-retinal fibrosis. The presence of one of these features excludes a patient only if the investigator judges the study eye to have irreversible macular edema.
- active bacterial, fungal or viral infections at the time of enrollment, e.g. hepatitis B or C infection. Patients with risk factors for hepatitis B should be tested for hepatitis B viral load and serological markers at screening (a positive HBV-DNA, HBsAg). Patients with risk factors for hepatitis C should be tested using HCVRNA-PCR at screening. A clinical history of hepatitis B or hepatitis C will exclude the patient from the study.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United Kingdom8 sites
Novartis Investigative Site
Bristol
Novartis Investigative Site
Frimley
Novartis Investigative Site
Liverpool
Novartis Investigative Site
London
Novartis Investigative Site
Oxford
Novartis Investigative site
Portsmouth
Novartis Investigative Site
Southampton
Novartis Investigator Site
Wolverhampton
United States4 sites
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Porter Adventist Hospital, Diagnostic Eye Laboratory
Denver, Colorado, 80210
Discover Vision Center
Independence, Missouri, 64055
Retinal Consultants Medical Group, Inc.
Sacramento, California
About this study
Official title: A Randomized, Double-masked, Parallel Group Study to Assess the Efficacy of Oral Everolimus, Either Alone or Added to Lucentis, in Patients With Neovascular Age-related Macular Degeneration
The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)
- Being tested
- Everolimus, Ranibizumab
- Keywords
- AMD, macular degeneration, Everolimus, Lucentis, Ranibizumab, Choroidal Neo-Vascular (CNV) age-onset macular degeneration, Age-related Macular Degeneration (AMD)
- 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.
EverolimusDrug
5 mg oral tablet
RanibizumabDrug
0.5 mg administered by intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Everolimus 5 mg | Experimental | 5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28 Receives: Drug: Everolimus |
| Ranibizumab 0.5 mg | Active comparator | Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline) Receives: Drug: Ranibizumab |
| Oral Everolimus (5mg) and Ranibizumab (0.5mg) | Active comparator | Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) Receives: Drug: Everolimus; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)
Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus
Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Choroidal Neo-Vascular Age-onset Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857259
- Sponsor's protocol ID
- CRAD001A2203
- Other IDs
- EudraCT number: 2008-003550-15
- Status last verified
- Jul 2011
- First submitted
- 4 Mar 2009
- Last updated
- 19 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Parallel Group Study to Assess the Efficacy of Oral Everolimus, Either Alone or Added to Lucentis, in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00857259
- Acronym / sponsor ID
- CRAD001A2203
- Keywords
- AMD, macular degeneration, Everolimus, Lucentis, Ranibizumab, Choroidal Neo-Vascular (CNV) age-onset macular degeneration, Age-related Macular Degeneration (AMD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 19 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Everolimus 5 mg | Experimental | Drug: Everolimus5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28 |
| Ranibizumab 0.5 mg | Active comparator | Drug: RanibizumabRanibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline) |
| Oral Everolimus (5mg) and Ranibizumab (0.5mg) | Active comparator | Drug: Everolimus, Drug: RanibizumabEverolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with neovascular Age-Related Macular Degeneration (AMD)
- Best corrected visual acuity ( BCVA) of 20/40 or worse in study eye
- Patients with predominantly classic, minimally classic, or occult choroidal neovascularization in the macula of one eye (the study eye) who have had an inadequate response to VEGF inhibitors in the study eye. Inadequate response is defined as a gain of less than one line of visual acuity and persistent macular edema (central sub-fiel thickness ≥ 300 μm as measured by Optical Coherence Tomography (OCT) despite a minimum of 3 treatments with Lucentis or Avastin
Key exclusion criteria (5 listed)
- Any concurrent ocular condition in the study eye that may result in substantial change in vision during the study
- Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke
- Patients who have macular edema in the study eye that, in the judgment of the investigator, is unlikely to respond to treatment. Examples of features that may guide the investigator's judgment about unresponsiveness are large regions of geographic atrophy, retinal angiomatous proliferation, or large regions of sub-retinal fibrosis. The presence of one of these features excludes a patient only if the investigator judges the study eye to have irreversible macular edema.
- active bacterial, fungal or viral infections at the time of enrollment, e.g. hepatitis B or C infection. Patients with risk factors for hepatitis B should be tested for hepatitis B viral load and serological markers at screening (a positive HBV-DNA, HBsAg). Patients with risk factors for hepatitis C should be tested using HCVRNA-PCR at screening. A clinical history of hepatitis B or hepatitis C will exclude the patient from the study.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Everolimus5 mg oral tablet | Drug | Everolimus 5 mg, Oral Everolimus (5mg) and Ranibizumab (0.5mg) |
| Ranibizumab0.5 mg administered by intravitreal injection | Drug | Oral Everolimus (5mg) and Ranibizumab (0.5mg), Ranibizumab 0.5 mg |
Primary outcome
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)
Time frame: Baseline and 4 weeks
Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.
1 secondary outcome
Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus
Time frame: Baseline and week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus and Ranibizumab in people with Choroidal Neo-Vascular Age-onset Macular Degeneration and Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 12 sites in 2 countries.
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 3 inclusion and 5 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 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT) (time frame: Baseline and 4 weeks). 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 19 Aug 2011.