Choroid NeovascularizationPhase 2NCT00395057
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
A Phase 2 study testing AGN 211745 and Ranibizumab 500µg in people with Choroid Neovascularization and Age-Related Macular Degeneration, run by Allergan at 3 sites in 3 countries.
Trial summary
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroid Neovascularization, Age-Related Macular Degeneration
- What is being tested?
- AGN 211745 and Ranibizumab 500µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2007to Feb 2009
- 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 or older with "wet" AMD as determined by an ophthalmologist
- decrease in visual acuity (20/40 to 20/640) in at least one eye
Who cannot join
- Uncontrolled systemic disease
- History of heart attack or stroke within one year of study entry
- Symptomatic coronary artery disease
- Cataracts that interfere with vision
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration
- Being tested
- AGN 211745, Ranibizumab 500µg
- 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.
AGN 211745Drug
Also called Sirna-027
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
AGN 211745Drug
Also called Sirna-027
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
AGN 211745Drug
Also called Sirna-027
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
Ranibizumab 500µgDrug
Also called Lucentis®
Ranibizumab 500µg injections at Day 1, Month 1, Month 2
| Study group | Role | What they receive |
|---|---|---|
| AGN 211745 Solution 1000 ug | Experimental | AGN 211745 Solution 1000 ug Receives: Drug: AGN 211745 |
| AGN 211745 Solution 300 ug | Experimental | AGN 211745 Solution 300 ug Receives: Drug: AGN 211745 |
| AGN 211745 Solution 100 ug | Experimental | AGN 211745 Solution 100 ug Receives: Drug: AGN 211745 |
| Ranibizumab 500 ug | Active comparator | Ranibizumab 500 ug Receives: Drug: Ranibizumab 500µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. 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: Month 3
Secondary outcomes (4)
Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3
Lesion size as assessed by FA and photography at month 3. 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.
Measured: Month 3
Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3
Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.
Measured: Month 3
Visual Functioning Questionnaire (VFQ) at Month 3
Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.
Measured: Month 3
Time to Treatment With Standard of Care at Month 6
Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionOct 2008
- Study completionFeb 2009
Why it stopped: The study was terminated early due to company decision (non-safety related).
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 Choroid 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
- 138 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
- NCT00395057
- Sponsor's protocol ID
- 211745-001
- Status last verified
- Aug 2015
- First submitted
- 31 Oct 2006
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00395057
- Acronym / sponsor ID
- 211745-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to company decision (non-safety related).
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Posted 13 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN 211745 Solution 1000 ug | Experimental | Drug: AGN 211745AGN 211745 Solution 1000 ug |
| AGN 211745 Solution 300 ug | Experimental | Drug: AGN 211745AGN 211745 Solution 300 ug |
| AGN 211745 Solution 100 ug | Experimental | Drug: AGN 211745AGN 211745 Solution 100 ug |
| Ranibizumab 500 ug | Active comparator | Drug: Ranibizumab 500µgRanibizumab 500 ug |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 years or older with "wet" AMD as determined by an ophthalmologist
- decrease in visual acuity (20/40 to 20/640) in at least one eye
Key exclusion criteria (4 listed)
- Uncontrolled systemic disease
- History of heart attack or stroke within one year of study entry
- Symptomatic coronary artery disease
- Cataracts that interfere with vision
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 |
|---|---|---|
| AGN 211745Also: Sirna-027AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2 | Drug | AGN 211745 Solution 1000 ug |
| AGN 211745Also: Sirna-027AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2 | Drug | AGN 211745 Solution 300 ug |
| AGN 211745Also: Sirna-027AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2 | Drug | AGN 211745 Solution 100 ug |
| Ranibizumab 500µgAlso: Lucentis®Ranibizumab 500µg injections at Day 1, Month 1, Month 2 | Drug | Ranibizumab 500 ug |
Primary outcome
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
Time frame: Month 3
Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. 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.
4 secondary outcomes
Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3
Time frame: Month 3
Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3
Time frame: Month 3
Visual Functioning Questionnaire (VFQ) at Month 3
Time frame: Month 3
Time to Treatment With Standard of Care at Month 6
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- 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 AGN 211745 and Ranibizumab 500µg in people with Choroid Neovascularization and Age-Related Macular Degeneration, 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 2 inclusion and 4 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 7 Sep 2015. 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 13 Dec 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?
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3 (time frame: Month 3). 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 7 Sep 2015.