Exudative Age-Related Macular DegenerationPhase 2NCT01849692

ESBA1008 Microvolume Study

A Phase 2 study testing ESBA1008 solution and Ranibizumab in people with Exudative Age-Related Macular Degeneration, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (AMD). 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?: ESBA1008 solution and Ranibizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: No sites listed yet
Study dates: Jun 2013to Jan 2015
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

Sign informed consent document;
Able to make the required study visits and follow instructions;
Age-related macular degeneration in the study eye;
Visual acuity within protocol-specified range;
340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent)
Other protocol-defined inclusion criteria may apply.

Who cannot join

Both eyes: Any active infection or inflammation;
Study eye: Any treatment for exudative age-related macular degeneration (AMD) other than vitamin supplements;
Study eye: Any current or history of macular or retinal disease;
Study eye: Any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss;
Study eye: Other ocular conditions or diseases that, in the opinion of the Investigator, could compromise visual acuity;
Study Eye: Uncontrolled glaucoma;

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History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product;
Women of childbearing potential who are lactating, pregnant, planning to become pregnant, or not using adequate birth control methods for the duration of the study;
Intraocular surgery within 3 months of baseline;
Study eye: Any history or current evidence of retinal angiomatous proliferation (RAP) lesions based on clinical exam;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Prospective, Two-Staged, Single-Masked Study to Evaluate the Effect of ESBA1008 Applied by Microvolume Injection or Infusion in Subjects With Exudative Age-Related Macular Degeneration

Read the detailed description

This 4-cohort study was conducted in 2 stages. Stage 1 consisted out of 2 Cohorts. In each cohort subjects were randomized 10:3 to either receive ESBA1008 (Cohort 1 : 2 injections, Cohort 2 : 1 infusion and 1 injection) or 2 Lucentis injections. Stage 2 was conducted similarly with a different dosing level for ESBA1008 (Cohort 3 and 4). Subjects had follow-up visits at Day 7 and Day 14. All cohorts receiving ESBA1008 on Day 0 also received ESBA1008 6mg/50 μL via injection on Day 28. After the Day 28 visit (all cohorts), subjects returned for follow up visits at Day 42 and Day 56.

Conditions: Exudative Age-Related Macular Degeneration
Being tested: ESBA1008 solution, Ranibizumab
Keywords: Exudative Age-Related Macular Degeneration, Wet AMD, Choroidal neovascularization (CNV), Vascular endothelial growth factor (VEGF)
Medical subject headings: Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESBA1008 solutionDrug
Intravitreal injection or infusion
RanibizumabDrug
Also called LUCENTIS®
Intravitreal injection

Study groups in NCT01849692
Study group	Role	What they receive
ESBA1008 1.2 mg/10 μL	Experimental	Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28 Receives: Drug: ESBA1008 solution
ESBA1008 1 mg/8.3 μL	Experimental	Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 Receives: Drug: ESBA1008 solution
ESBA1008 0.6 mg/10 μL	Experimental	Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 Receives: Drug: ESBA1008 solution
ESBA1008 0.5 mg/8.3 μL	Experimental	Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 Receives: Drug: ESBA1008 solution
Ranibizumab 0.5 mg in 50 μL	Active comparator	Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28 Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:
- Greater than or equal to 4 letter gain in BCVA at Day 14
- Greater than or equal to 4 letter gain in BCVA at Day 28
- Greater than or equal to 80 micron decrease in CSFT at Day 14
- Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 14, Day 28

Secondary outcomes (8)

Change From Baseline in BCVA, Cohort 1
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 2
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 3
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 4
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 1
CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 2
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 3
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 4
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jan 2015

First posted8 May 2013 (estimated)
Study startJun 2013
Primary completionJan 2015
Study completionJan 2015

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.
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: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01849692
Sponsor's protocol ID: C-13-001
Status last verified: Jan 2016
First submitted: 6 May 2013
Last updated: 24 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
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RecruitingObservational study
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MMP-9 Inhibition for Recalcitrant Wet AMD
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All Exudative Age-Related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Two-Staged, Single-Masked Study to Evaluate the Effect of ESBA1008 Applied by Microvolume Injection or Infusion in Subjects With Exudative Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT01849692
Acronym / sponsor ID: C-13-001
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Exudative Age-Related Macular Degeneration, Wet AMD, Choroidal neovascularization (CNV), Vascular endothelial growth factor (VEGF)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 8 May 2013 (estimated)
Results: Posted 25 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
ESBA1008 1.2 mg/10 μL	Experimental	Drug: ESBA1008 solutionCohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28
ESBA1008 1 mg/8.3 μL	Experimental	Drug: ESBA1008 solutionCohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28
ESBA1008 0.6 mg/10 μL	Experimental	Drug: ESBA1008 solutionCohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28
ESBA1008 0.5 mg/8.3 μL	Experimental	Drug: ESBA1008 solutionCohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28
Ranibizumab 0.5 mg in 50 μL	Active comparator	Drug: RanibizumabCohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Sign informed consent document;
Able to make the required study visits and follow instructions;
Age-related macular degeneration in the study eye;
Visual acuity within protocol-specified range;
340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent)

Key exclusion criteria (11 listed)

Both eyes: Any active infection or inflammation;
Study eye: Any treatment for exudative age-related macular degeneration (AMD) other than vitamin supplements;
Study eye: Any current or history of macular or retinal disease;
Study eye: Any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss;
Study eye: Other ocular conditions or diseases that, in the opinion of the Investigator, could compromise visual acuity;

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
ESBA1008 solutionIntravitreal injection or infusion	Drug	ESBA1008 0.5 mg/8.3 μL, ESBA1008 0.6 mg/10 μL, ESBA1008 1 mg/8.3 μL, ESBA1008 1.2 mg/10 μL
RanibizumabAlso: LUCENTIS®Intravitreal injection	Drug	Ranibizumab 0.5 mg in 50 μL

Primary outcome

Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
Time frame: Baseline, Day 14, Day 28
A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline: * Greater than or equal to 4 letter gain in BCVA at Day 14 * Greater than or equal to 4 letter gain in BCVA at Day 28 * Greater than or equal to 80 micron decrease in CSFT at Day 14 * Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.

8 secondary outcomes

Change From Baseline in BCVA, Cohort 1
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 2
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 3
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 4
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 1
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 2
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 3
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 4
Time frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

Results and safety

Results posted to the registry on 25 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - ESBA	10	10
Cohort 1 - Ranibizumab	3	3
Cohort 2 - ESBA	10	10
Cohort 2 - Ranibizumab	3	3
Cohort 3 - ESBA	10	10
Cohort 3 - Ranibizumab	3	3
Cohort 4 - ESBA	10	10
Cohort 4 - Ranibizumab	3	3

Primary outcome: Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28

Time frame: Baseline, Day 14, Day 28. Number (90% Confidence Interval). Unit: percentage of responders

Measure	Cohort 1 n = 13	Cohort 2 n = 13	Cohort 3 n = 13	Cohort 4 n = 13
ESBA, n=10	70 (39.3 to 91.3)	60 (30.4 to 85.0)	80 (49.3 to 96.3)	60 (30.4 to 85.0)
LUCENTIS, n=3	100 (36.8 to 100.0)	100 (36.8 to 100.0)	33.3 (1.7 to 86.5)	66.7 (13.5 to 98.3)

Population analysed: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, "n" is the number of subjects in each arm group.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 ESBA 1.2 mg INJ	0 of 10 (0%)	6 of 10 (60%)	Not reported
Stage 1 ESBA 1 mg INF	0 of 10 (0%)	4 of 10 (40%)	Not reported
Stage 1 LUCENTIS 0.5 mg INJ	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Stage 2 ESBA 0.6 mg INJ	1 of 10 (10%)	6 of 10 (60%)	Not reported
Stage 2 ESBA 0.5 mg INF	0 of 10 (0%)	7 of 10 (70%)	Not reported
Stage 2 LUCENTIS 0.5 mg INJ	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Pretreatment	1 of 107 (0.9%)	3 of 107 (2.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
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.

Clinical Project Group Leader, GCRA, Pharma study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ESBA1008 solution and Ranibizumab in people with Exudative Age-Related Macular Degeneration, run by Alcon Research.

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 11 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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 25 Feb 2016). 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 Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28 (time frame: Baseline, Day 14, Day 28). 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 NCT01849692.

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 24 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.