Subfoveal Choroidal NeovascularizationPhase 2NCT01122511
Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
A Phase 2 study testing 700 ug dexamethasone and ranibizumab in people with Subfoveal Choroidal Neovascularization and Age-Related Maculopathy, run by Allergan at 2 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subfoveal Choroidal Neovascularization, Age-Related Maculopathy
- What is being tested?
- 700 ug dexamethasone and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to May 2011
- 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
- Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
- Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
- Visual acuity between 20/320 and 20/40
Who cannot join
- Active ocular infection
- Contraindication to pupil dilation in either eye
- Eye surgery including cataract surgery and/or laser of any type within 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Abilene, Texas
Study site
Fort Myers, Florida
About this study
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
- Being tested
- 700 ug dexamethasone, ranibizumab, sham
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
700 ug dexamethasoneDrug
Also called OZURDEX®
Intravitreal injection of 700 ug dexamethasone into study eye
ranibizumabBiological
Also called Lucentis®
Intravitreal injection of ranibizumab into study eye
shamOther
Sham needle-less injection administered in the study eye
| Study group | Role | What they receive |
|---|---|---|
| 700 ug dexamethasone and ranibizumab | Experimental | Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye Receives: Drug: 700 ug dexamethasone; Biological: ranibizumab |
| ranibizumab and sham | Active comparator | Intravitreal injection of ranibizumab and Sham into study eye Receives: Biological: ranibizumab; Other: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
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, Month 12
Secondary outcomes (3)
The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12
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, Month 12
Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
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 Month 12.
Measured: Baseline, Month 12
Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
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 was performed on the study eye after dilation at baseline and Week 12.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The study was terminated early due to difficulties with patient recruitment.
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 Subfoveal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 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
- NCT01122511
- Sponsor's protocol ID
- 206207-021
- Status last verified
- Aug 2012
- First submitted
- 11 May 2010
- Last updated
- 5 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 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01122511
- Acronym / sponsor ID
- 206207-021
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to difficulties with patient recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 700 ug dexamethasone and ranibizumab | Experimental | Drug: 700 ug dexamethasone, Biological: ranibizumabIntravitreal injection of 700 ug dexamethasone and ranibizumab into study eye |
| ranibizumab and sham | Active comparator | Biological: ranibizumab, Other: shamIntravitreal injection of ranibizumab and Sham into study eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
- Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
- Visual acuity between 20/320 and 20/40
Key exclusion criteria (3 listed)
- Active ocular infection
- Contraindication to pupil dilation in either eye
- Eye surgery including cataract surgery and/or laser of any type within 3 months
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 |
|---|---|---|
| 700 ug dexamethasoneAlso: OZURDEX®Intravitreal injection of 700 ug dexamethasone into study eye | Drug | 700 ug dexamethasone and ranibizumab |
| ranibizumabAlso: Lucentis®Intravitreal injection of ranibizumab into study eye | Biological | 700 ug dexamethasone and ranibizumab, ranibizumab and sham |
| shamSham needle-less injection administered in the study eye | Other | ranibizumab and sham |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
Time frame: Baseline, Month 12
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.
3 secondary outcomes
The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12
Time frame: Baseline, Month 12
Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
Time frame: Baseline, Month 12
Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
- 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.
Medical Director study director
Allergan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 700 ug dexamethasone and ranibizumab in people with Subfoveal Choroidal Neovascularization and Age-Related Maculopathy, run by Allergan at 2 sites in United States.
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 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 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 2 sites in 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 5 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 Best Corrected Visual Acuity (BCVA) at Month 12 (time frame: Baseline, Month 12). 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 Sep 2012.