ESBA1008 Microvolume Study

NCT01849692 | Completed Phase 2 Results

• 1 other identifier: C-13-001
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Exudative Age-Related Macular Degeneration

Keywords

Exudative Age-Related Macular Degeneration; Wet AMD; Choroidal neovascularization (CNV); Vascular endothelial growth factor (VEGF)

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28

  A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline: * Greater than or equal to 4 letter gain in BCVA at Day 14 * Greater than or equal to 4 letter gain in BCVA at Day 28 * Greater than or equal to 80 micron decrease in CSFT at Day 14 * Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.

  Baseline, Day 14, Day 28

Secondary Outcomes (8)

• Change From Baseline in BCVA, Cohort 1

  Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

• Change From Baseline in BCVA, Cohort 2

  Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

• Change From Baseline in BCVA, Cohort 3

  Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

• Change From Baseline in BCVA, Cohort 4

  Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

• Change From Baseline in CSFT, Cohort 1

  Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

Study Arms (5)

ESBA1008 1.2 mg/10 μL

EXPERIMENTAL

Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28

Drug: ESBA1008 solution

ESBA1008 1 mg/8.3 μL

EXPERIMENTAL

Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28

Drug: ESBA1008 solution

ESBA1008 0.6 mg/10 μL

EXPERIMENTAL

Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28

Drug: ESBA1008 solution

ESBA1008 0.5 mg/8.3 μL

EXPERIMENTAL

Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28

Drug: ESBA1008 solution

Ranibizumab 0.5 mg in 50 μL

ACTIVE COMPARATOR

Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28

Drug: Ranibizumab

Interventions

ESBA1008 solution DRUG

Intravitreal injection or infusion

ESBA1008 0.5 mg/8.3 μL; ESBA1008 0.6 mg/10 μL; ESBA1008 1 mg/8.3 μL; ESBA1008 1.2 mg/10 μL

Ranibizumab DRUG

Intravitreal injection

Also known as: LUCENTIS®

Ranibizumab 0.5 mg in 50 μL

Eligibility Criteria

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

You may qualify if:

• 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;
• μm minimal central subfield thickness (CSFT; Spectralis Equivalent)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Project Group Leader, 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 24, 2016
• Results First Posted: February 25, 2016

Record last verified: 2016-01