Age-Related Macular DegenerationPhase 2EMERALDNCT00766337
Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
A Phase 2 study testing Sirolimus in combination with ranibizumab in people with Age-Related Macular Degeneration and Choroidal Neovascularization, run by Santen Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal 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
- Age-Related Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- Sirolimus in combination with ranibizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Mar 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve
- Visual acuity of 20/40 to 20/200 in the study eye
Who cannot join
- Any other ocular disease that could compromise vision in the study eye
- Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
Trial locations and contacts
1 site in 1 country.
United States1 site
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
About this study
Official title: A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
- Being tested
- Sirolimus in combination with ranibizumab, Placebo in combination with ranibizumab
- Keywords
- wet 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.
Sirolimus in combination with ranibizumabDrug
Also called MS-R001, rapamycin, Lucentis
Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Sirolimus in combination with ranibizumabDrug
Also called MS-R002, rapamycin, Lucentis
Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Placebo in combination with ranibizumabDrug
Also called vehicle, Lucentis
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 | Experimental | Not described Receives: Drug: Sirolimus in combination with ranibizumab |
| Dose Group 2 | Experimental | Not described Receives: Drug: Sirolimus in combination with ranibizumab |
| Dose Group 3 | Placebo comparator | Not described Receives: Drug: Placebo in combination with ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity by ETDRS
Measured: 120 days
Secondary outcomes (2)
Retinal thickness
Measured: 120 days
Safety across treatment groups
Measured: Through 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Responsible party
- Sponsor
- Investigators
- Joel Naor, MD, Study director, MacuSight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766337
- Sponsor's protocol ID
- AMD-003
- Acronym
- EMERALD
- Status last verified
- Jul 2010
- First submitted
- 1 Oct 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00766337
- Acronym / sponsor ID
- EMERALD / AMD-003
- Keywords
- wet AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Oct 2008 (estimated)
- 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.
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 | Experimental | Drug: Sirolimus in combination with ranibizumab |
| Dose Group 2 | Experimental | Drug: Sirolimus in combination with ranibizumab |
| Dose Group 3 | Placebo comparator | Drug: Placebo in combination with ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve
- Visual acuity of 20/40 to 20/200 in the study eye
Key exclusion criteria (2 listed)
- Any other ocular disease that could compromise vision in the study eye
- Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
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 |
|---|---|---|
| Sirolimus in combination with ranibizumabAlso: MS-R001, rapamycin, LucentisCombination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period. | Drug | Dose Group 1 |
| Sirolimus in combination with ranibizumabAlso: MS-R002, rapamycin, LucentisCombination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period. | Drug | Dose Group 2 |
| Placebo in combination with ranibizumabAlso: vehicle, LucentisCombination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period. | Drug | Dose Group 3 |
Primary outcome
Best-corrected visual acuity by ETDRS
Time frame: 120 days
2 secondary outcomes
Retinal thickness
Time frame: 120 days
Safety across treatment groups
Time frame: Through 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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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.
Joel Naor, MD study director
MacuSight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus in combination with ranibizumab in people with Age-Related Macular Degeneration and Choroidal Neovascularization, run by Santen Inc. at 1 site 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 2 inclusion and 2 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 10 Jan 2013. 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 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. Some participants in this study may receive a placebo. 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?
The study was stopped early. 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?
Best-corrected visual acuity by ETDRS (time frame: 120 days). 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 10 Jan 2013.