Clinical trial NCT01849692: ESBA1008 Microvolume 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Exudative Age-Related Macular Degeneration
Wet AMD
Choroidal neovascularization (CNV)
Vascular endothelial growth factor (VEGF)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-05-08
Enrollment: 107
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 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
timeFrame: Baseline, Day 14, Day 28
Secondary outcomes:
measure: Change From Baseline in BCVA, Cohort 1
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in BCVA, Cohort 2
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in BCVA, Cohort 3
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in BCVA, Cohort 4
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in CSFT, Cohort 1
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in CSFT, Cohort 2
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in CSFT, Cohort 3
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
measure: Change From Baseline in CSFT, Cohort 4
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Project Group Leader, GCRA, Pharma
role: STUDY_DIRECTOR
References: