Efficacy and Safety Study of ESBA1008 Versus EYLEA®

NCT01796964 | Completed Phase 2 Results

• 1 other identifier: C-12-006
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.

Conditions

Exudative Age-Related Macular Degeneration

Keywords

Age-Related Macular Degeneration; Wet; Exudative; AMD; Intravitreal injection; Retina

Outcome Measures

Primary Outcomes (1)

• Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12

  This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.

  Baseline (Day 0), Week 12

Secondary Outcomes (8)

• BCVA Change From Baseline (No. of Letters) to Week 16

  Baseline (Day 0), Week 16

• BCVA Change From Baseline (No. of Letters) by Visit

  Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

• Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56

  Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

• Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56

  Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

• One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month

  Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56

Study Arms (2)

ESBA1008

EXPERIMENTAL

ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol

Drug: ESBA1008 solution

EYLEA

ACTIVE COMPARATOR

Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol

Drug: Aflibercept

Interventions

ESBA1008 solution DRUG

For intravitreal (IVT) injection

ESBA1008

Aflibercept DRUG

For intravitreal (IVT) injection

Also known as: EYLEA®

EYLEA

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Give written informed consent; be able to make the required study visits and follow instructions.
• Diagnosis of wet age-related macular degeneration, as specified in protocol.
• Best-corrected visual acuity (BCVA) as specified in protocol

You may not qualify if:

• Either eye: Any active ocular or periocular infection or active intraocular inflammation.
• Study eye: Any approved or investigational treatment for exudative AMD other than vitamin supplements.
• Study eye: Any current or history of macular or retinal disease other than exudative AMD.
• Study eye: Any concurrent intraocular condition that, in the opinion of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat vision loss, or that limits the potential to gain visual acuity with the investigational product.
• Study eye: Uncontrolled glaucoma.
• Study eye: Any ocular disease that, in the opinion of the Investigator, could compromise the visual acuity.
• Study eye: History of eye surgery, as specified in protocol.
• Study eye: Use of corticosteroids, as specified in protocol.
• Any medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or safe administration of investigational product.
• Any screening laboratory result that, in the opinion of the Investigator, would make the patient unsuitable for study participation.
• History of hypersensitivity to any component used in the study, as assessed by the Investigator.
• Women of childbearing potential: Lactating, pregnant, plan to become pregnant, or not using adequate birth control, as specified in protocol.
• Participation in an investigational drug or device study within time period specified in protocol.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• Dugel PU, Jaffe GJ, Sallstig P, Warburton J, Weichselberger A, Wieland M, Singerman L. Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology. 2017 Sep;124(9):1296-1304. doi: 10.1016/j.ophtha.2017.03.057. Epub 2017 May 24.

  PMID: 28551167 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Project Group Lead, GCRA, Pharma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, GCRA, Pharma

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2014
• Last Updated: February 9, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-01