Exudative Age-Related Macular DegenerationPhase 2RACENCT01157065
Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
A Phase 2 study testing AL-78898A and Ranibizumab in people with Exudative Age-Related Macular Degeneration, run by Alcon Research at 1 site in United States.
Trial summary
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- What is being tested?
- AL-78898A and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2012
- 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
- Willing to give informed consent, make the required study visits and follow instructions;
- Newly diagnosed with exudative age-related macular degeneration (AMD);
- Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
- Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
- No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- History or current evidence of macular or retinal disease other than exudative AMD (study eye);
- Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
- Any evidence of vitreous hemorrhage (study eye);
- History or evidence of surgery (study eye), as specified in protocol;
- Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
- A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol;
Show all 12Show fewer
- History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study
- History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator;
- Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study;
- Participation in any ocular or non-ocular investigational study within 30 days of screening;
- Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.
Read the detailed description
The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.
- Being tested
- AL-78898A, Ranibizumab
- Keywords
- Wet AMD, Intravitreal Injection, Macular Degeneration, VEGF treatment
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-78898ADrug
Investigational treatment
RanibizumabDrug
Also called LUCENTIS®
Anti-vascular endothelial growth factor (VEGF) treatment
| Study group | Role | What they receive |
|---|---|---|
| AL-78898A | Experimental | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up Receives: Drug: AL-78898A |
| Lucentis | Active comparator | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Measured: Week 4
Incidence of Events of Special Interest (ESI)
An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionApr 2012
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 Exudative Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mehdi Hosseini, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157065
- Sponsor's protocol ID
- C-09-067
- Acronym
- RACE
- Status last verified
- Apr 2013
- First submitted
- 2 Jul 2010
- Last updated
- 4 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD
- ClinicalTrials.gov ID
- NCT01157065
- Acronym / sponsor ID
- RACE / C-09-067
- Keywords
- Wet AMD, Intravitreal Injection, Macular Degeneration, VEGF treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 4 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.
Detailed description
The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-78898A | Experimental | Drug: AL-78898ASingle 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| Lucentis | Active comparator | Drug: RanibizumabSingle 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to give informed consent, make the required study visits and follow instructions;
- Newly diagnosed with exudative age-related macular degeneration (AMD);
- Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
- Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
- No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;
Key exclusion criteria (12 listed)
- History or current evidence of macular or retinal disease other than exudative AMD (study eye);
- Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
- Any evidence of vitreous hemorrhage (study eye);
- History or evidence of surgery (study eye), as specified in protocol;
- Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
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 |
|---|---|---|
| AL-78898AInvestigational treatment | Drug | AL-78898A |
| RanibizumabAlso: LUCENTIS®Anti-vascular endothelial growth factor (VEGF) treatment | Drug | Lucentis |
Primary outcome
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
Time frame: Week 4
The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Incidence of Events of Special Interest (ESI)
Time frame: Up to Day 30
An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- 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.
Mehdi Hosseini study director
Alcon Research
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 AL-78898A and Ranibizumab in people with Exudative Age-Related Macular Degeneration, run by Alcon Research 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 6 inclusion and 12 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 4 Jun 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. 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 4 Jun 2013). 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?
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4 (time frame: Week 4). The study lists 2 primary outcomes in all. 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 4 Jun 2013.