Age-Related Macular DegenerationPhase 2NCT01089517
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
A Phase 2 study testing E10030 plus Lucentis and Lucentis in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- E10030 plus Lucentis and Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subfoveal choroidal neovascularization (CNV) due to AMD
Who cannot join
- Any of the following underlying diseases including:
- Diabetes mellitus
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
- Clinically significant impaired renal or hepatic function.
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry.
- Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmetto Retinal Center
West Columbia, South Carolina, 29169
About this study
Official title: A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Read the detailed description
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 sham + Lucentis® 0. 5 mg/eye
Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.
Primary Efficacy Endpoint:
The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit
Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.
Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- E10030 plus Lucentis, Lucentis
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E10030 plus LucentisDrug
once a month intravitreal injection
LucentisDrug
10 mg/mL intravitreal injection monthly
| Study group | Role | What they receive |
|---|---|---|
| Lucentis | Active comparator | Not described Receives: Drug: Lucentis |
| E10030 low dose plus Lucentis | Experimental | Not described Receives: Drug: E10030 plus Lucentis |
| E10030 high dose plus Lucentis | Experimental | Not described Receives: Drug: E10030 plus Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Visual Acuity From Baseline at the Week 24 Visit
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
Measured: 24 Weeks
Secondary outcomes (2)
The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit
The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit
Measured: 24 weeks
Proportion of Patients With at Least 1 Adverse Event
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089517
- Sponsor's protocol ID
- OPH1001
- Status last verified
- Apr 2017
- First submitted
- 12 Mar 2010
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01089517
- Acronym / sponsor ID
- OPH1001
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Ophthotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 3 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Detailed description
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 sham + Lucentis® 0. 5 mg/eye
Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.
Primary Efficacy Endpoint:
The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit
Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.
Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lucentis | Active comparator | Drug: Lucentis |
| E10030 low dose plus Lucentis | Experimental | Drug: E10030 plus Lucentis |
| E10030 high dose plus Lucentis | Experimental | Drug: E10030 plus Lucentis |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subfoveal choroidal neovascularization (CNV) due to AMD
Key exclusion criteria (7 listed)
- Diabetes mellitus
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
- Clinically significant impaired renal or hepatic function.
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry.
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 |
|---|---|---|
| E10030 plus Lucentisonce a month intravitreal injection | Drug | E10030 high dose plus Lucentis, E10030 low dose plus Lucentis |
| Lucentis10 mg/mL intravitreal injection monthly | Drug | Lucentis |
Primary outcome
Mean Change in Visual Acuity From Baseline at the Week 24 Visit
Time frame: 24 Weeks
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
2 secondary outcomes
The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit
Time frame: 24 weeks
Proportion of Patients With at Least 1 Adverse Event
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 E10030 plus Lucentis and Lucentis in people with Age-Related Macular Degeneration, run by Ophthotech Corporation 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 1 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 19 Mar 2024. 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 3 Jan 2014). 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 Change in Visual Acuity From Baseline at the Week 24 Visit (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089517, which also lists 1 linked publication.
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 19 Mar 2024.