Clinical trial NCT01796964: Efficacy and Safety Study of ESBA1008 Versus EYLEA®
Official title: A Prospective, Randomized, Double-Masked, Multicenter, Two Arm Study Comparing the Efficacy and Safety of ESBA1008 Versus EYLEA® in Subjects With Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Age-Related Macular Degeneration
Wet
Exudative
AMD
Intravitreal injection
Retina
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 173
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Other protocol-specified inclusion criteria may apply.

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.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
timeFrame: Baseline (Day 0), Week 12
Secondary outcomes:
measure: BCVA Change From Baseline (No. of Letters) to Week 16
timeFrame: Baseline (Day 0), Week 16
measure: BCVA Change From Baseline (No. of Letters) by Visit
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56
measure: One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month
timeFrame: Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56
measure: One-Month BCVA Changes (No. of Letters) Following Treatment by Visit
timeFrame: Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52
measure: Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group
timeFrame: Week 36, Week 44, Week 48, Week 56
measure: Central Subfield Thickness (CSFT) Change From Baseline by Visit
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, GCRA, Pharma
role: STUDY_DIRECTOR
References:
citation: 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.