Choroidal NeovascularizationPhase 2NCT00775411
Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
A Phase 2 study testing dexamethasone and ranibizumab in people with Choroidal Neovascularization and Age-Related Maculopathy, run by Allergan at 3 sites in 3 countries.
Trial summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroidal Neovascularization, Age-Related Maculopathy
- What is being tested?
- dexamethasone and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2008to Apr 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
- 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD
- Central retinal thickness ≥ 300 µm
- Visual acuity between 20/400 and 20/32
- Eligible for Anti-VEGF therapy
Who cannot join
- Previous treatment for CNV due to AMD
- High eye pressure
- Glaucoma
- Uncontrolled systemic disease
- Known allergy to the study medications
- Recent eye surgery or injections in the eye
- Female subjects that are of childbearing potential
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.
- Being tested
- dexamethasone, ranibizumab
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called Posurdex
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
ranibizumabBiological
Also called Lucentis®
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
| Study group | Role | What they receive |
|---|---|---|
| 700 µg dexamethasone and ranibizumab | Experimental | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye. Receives: Drug: dexamethasone; Biological: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.
Measured: Baseline, Week 4
Secondary outcomes (2)
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Week 26
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26
Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionApr 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 NeovascularizationStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775411
- Sponsor's protocol ID
- 206207-019
- Status last verified
- Aug 2012
- First submitted
- 16 Oct 2008
- Last updated
- 3 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00775411
- Acronym / sponsor ID
- 206207-019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Posted 3 Sep 2012
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 evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 700 µg dexamethasone and ranibizumab | Experimental | Drug: dexamethasone, Biological: ranibizumab700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD
- Central retinal thickness ≥ 300 µm
- Visual acuity between 20/400 and 20/32
- Eligible for Anti-VEGF therapy
Key exclusion criteria (7 listed)
- Previous treatment for CNV due to AMD
- High eye pressure
- Glaucoma
- Uncontrolled systemic disease
- Known allergy to the study medications
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 |
|---|---|---|
| dexamethasoneAlso: Posurdex700 µg dexamethasone intravitreal injection at Day 1 in the study eye. | Drug | 700 µg dexamethasone and ranibizumab |
| ranibizumabAlso: Lucentis®Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye. | Biological | 700 µg dexamethasone and ranibizumab |
Primary outcome
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4
Time frame: Baseline, Week 4
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.
2 secondary outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26
Time frame: Baseline, Week 26
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone and ranibizumab in people with Choroidal Neovascularization and Age-Related Maculopathy, run by Allergan at 3 sites in 3 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, Philippines. 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 3 Sep 2012). 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 From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 (time frame: Baseline, Week 4). 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 3 Sep 2012.