Efficacy and Safety Study of ESBA1008 Versus EYLEA®

NCT ID: NCT01796964

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-08-31

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.

Detailed Description

This study consisted of 16 visits (Screening, Baseline [Day 0], and 14 post-baseline assessment visits) that occurred at 4-week intervals through Week 56. Enrolled subjects were randomized 1:1 to receive ESBA1008 or EYLEA. All subjects received active intravitreal (IVT) injections at baseline with 2 additional loading doses of the assigned investigational product at 4-week intervals (ie, at Weeks 4 and 8) and then received further injections at 8-weeks intervals at Weeks 16, 24, and 32. Subjects in the ESBA1008 group also received an injection at Week 44, while subjects in the EYLEA group also received injections at Weeks 40 and 48. To maintain the study masking, subjects in the ESBA1008 group received sham injections at Weeks 40 and 48 (when the subjects in the EYLEA group received active injections), while subjects in the EYLEA group received a sham injection at Week 44 (when the subjects in the ESBA1008 group received an active injection). All subjects were followed up to Week 56. Week 40 visit was the end of assessment period for the 8-week treatment cycle.

Conditions

Exudative Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ESBA1008

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

Group Type: EXPERIMENTAL

ESBA1008 solution

Intervention Type: DRUG

For intravitreal (IVT) injection

EYLEA

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

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

For intravitreal (IVT) injection

Interventions

ESBA1008 solution

For intravitreal (IVT) injection

Intervention Type: DRUG

Aflibercept

For intravitreal (IVT) injection

Intervention Type: DRUG

Other Intervention Names

EYLEA®

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, GCRA, Pharma

Role: STUDY_DIRECTOR

Alcon Research

References

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.

Reference Type: DERIVED

PMID: 28551167 (View on PubMed)

Other Identifiers

C-12-006

Identifier Type: -

Identifier Source: org_study_id