Exudative Age-Related Macular DegenerationPhase 1/2NCT01304693

ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients

A Phase 1/2 study testing ESBA1008 solution and Ranibizumab 0.5 mg 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 was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients 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 0.5 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 376 participants
Where: No sites listed yet
Study dates: Oct 2010to Mar 2013
Phase: Phase 1/2
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

Provide written informed consent.
Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
Evidence of subretinal fluid or retinal cystic changes with a CSFT of > 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Previously administered therapy, approved or investigational, for wet AMD in the study eye.
Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
Uncontrolled or advanced glaucoma in the study eye.
Use of systemic or topical ocular corticosteroids.
History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.

Show all 9Show fewer

Abnormal or unsuitable laboratory results at Screening visit.
Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration

Read the detailed description

This study was conducted in two parts. In Part 1, patients were initially randomized (5:2) to receive either ESBA1008 at the lowest dose (Dose A) or LUCENTIS. After Safety Committee review, a second cohort was enrolled and randomized (5:2) to the next higher dose of ESBA1008 (Dose B). Safety review and enrollment of patients into the third cohort (Dose C) and fourth cohort (Dose D) was conducted in the same manner. Part 2, the expansion period, consisted of 2 arms. In the first arm patients were randomized to receive ESBA1008 Dose C or LUCENTIS (43:44) . In the second arm, patients were randomized to ESBA1008 Doses A:B:D:Lucentis (5:30:35:9). All enrolled patients (Part 1 and Part 2) were evaluated for safety and efficacy across 13 study visits, including Screening, Randomization, and 11 post- treatment follow-up visits (Day 1 through Month 6).

Conditions: Exudative Age-Related Macular Degeneration
Being tested: ESBA1008 solution, Ranibizumab 0.5 mg
Keywords: AMD, Wet AMD, Exudative, CNV

What participants receive

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

ESBA1008 solutionBiological
Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)
Ranibizumab 0.5 mgBiological
Also called LUCENTIS®
Administered as a single intravitreal injection

Study groups in NCT01304693
Study group	Role	What they receive
ESBA1008	Experimental	ESBA1008 solution, single intravitreal injection Receives: Biological: ESBA1008 solution
LUCENTIS	Active comparator	Ranibizumab 0.5 mg, single intravitreal injection Receives: Biological: Ranibizumab 0.5 mg

What is being measured

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

Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)
CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.
Measured: Baseline, Month 1

Secondary outcomes (1)

Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria
Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.
Measured: Time to event, up to Month 6

Timeline

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

Oct 2010Mar 2013

First posted25 Feb 2011 (estimated)
Study startOct 2010
Primary completionMar 2013
Study completionMar 2013

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 376 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01304693
Sponsor's protocol ID: C-10-083
Status last verified: Jul 2014
First submitted: 24 Feb 2011
Last updated: 17 Jul 2014
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

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration

All Exudative Age-Related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT01304693
Acronym / sponsor ID: C-10-083
Conditions: Exudative Age-Related Macular Degeneration
Keywords: AMD, Wet AMD, Exudative, CNV
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 376 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 25 Feb 2011 (estimated)
Results: Posted 7 May 2014

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: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ESBA1008	Experimental	Biological: ESBA1008 solutionESBA1008 solution, single intravitreal injection
LUCENTIS	Active comparator	Biological: Ranibizumab 0.5 mgRanibizumab 0.5 mg, single intravitreal injection

Who may qualify

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

Key inclusion criteria (6 listed)

Provide written informed consent.
Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
Evidence of subretinal fluid or retinal cystic changes with a CSFT of > 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.

Key exclusion criteria (9 listed)

Previously administered therapy, approved or investigational, for wet AMD in the study eye.
Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
Uncontrolled or advanced glaucoma in the study eye.
Use of systemic or topical ocular corticosteroids.

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 solutionAdministered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)	Biological	ESBA1008
Ranibizumab 0.5 mgAlso: LUCENTIS®Administered as a single intravitreal injection	Biological	LUCENTIS

Primary outcome

Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)
Time frame: Baseline, Month 1
CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.

1 secondary outcome

Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria
Time frame: Time to event, up to Month 6

Results and safety

Results posted to the registry on 7 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ESBA1008 Dose A	10	10
ESBA1008 Dose B	35	35
ESBA1008 Dose C	48	47
ESBA1008 Dose D	40	39
Lucentis	61	60

Primary outcome: Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)

Time frame: Baseline, Month 1. Mean (Standard Deviation). Unit: microns

Measure	ESBA1008 Dose A n = 10	ESBA1008 Dose B n = 35	ESBA1008 Dose C n = 48	ESBA1008 Dose D n = 40	Lucentis n = 61
Value	-142.3 (78.8)	-181.6 (107.2)	-175.6 (138.9)	-174.9 (101.3)	-159.4 (110.1)

Population analysed: This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT). Efficacy data from visits occurring after standard of care (SoC) were censored and replaced based on LOCF,i.e. by the data observed at the time of the SoC decision.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (2 years, 5 months). An AE was considered to be any untoward medical occurrence in a patient exposed to study drug. The AE did not have to have had a causal relationship with the study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ESBA1008 Dose A	0 of 11 (0%)	1 of 11 (9.1%)	Not reported
ESBA1008 Dose B	4 of 31 (12.9%)	10 of 31 (32.3%)	Not reported
ESBA1008 Dose C	3 of 47 (6.4%)	17 of 47 (36.2%)	Not reported
ESBA1008 Dose D	3 of 44 (6.8%)	16 of 44 (36.4%)	Not reported
Lucentis	7 of 61 (11.5%)	13 of 61 (21.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Exudative Age-Related Macular Degeneration

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration

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.

Georges Weissgerber, MD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ESBA1008 solution and Ranibizumab 0.5 mg 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 9 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 17 Jul 2014. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 May 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?

Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT) (time frame: Baseline, Month 1). 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 NCT01304693.

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 17 Jul 2014.