ESBA1008 Microvolume Study

Exudative Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849692
• Other study ID #: C-13-001
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2013
• Last updated: January 29, 2016
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardAustralia: Human Research Ethics CommitteeDominican Republic: Consejo Nacional de Bioetica en Salud
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exudative Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• ESBA1008 solution
Intravitreal injection or infusion
• Ranibizumab
Intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. One eye (study eye) contributed to the analysis.	Baseline, Day 14, Day 28	No
Secondary	Change From Baseline in BCVA, Cohort 1	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 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in BCVA, Cohort 2	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 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in BCVA, Cohort 3	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 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in BCVA, Cohort 4	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 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in CSFT, Cohort 1	CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.	Baseline, Day 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in CSFT, Cohort 2	CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.	Baseline, Day 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in CSFT, Cohort 3	CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.	Baseline, Day 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Change From Baseline in CSFT, Cohort 4	CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.	Baseline, Day 7, Day 14, Day 28, Day 42, Day 56	No