Loading clinical trials...

COMPLETEDPHASE2

ESBA1008 Microvolume Study

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

NCT01849692•Alcon Research

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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)

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;

Key Dates

Start Date

June 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

March 24, 2016

Enrollment

107

ACTUAL participants

Conditions

Exudative Age-Related Macular Degeneration

Interventions

ESBA1008 solution

DRUG

Ranibizumab

DRUG

A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

NCT04200248

Exudative Age-related Macular Degeneration

View study

COMPLETEDPHASE1/PHASE2

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

NCT05703867

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ESBA1008 Microvolume Study

Inclusion Criteria

Exclusion Criteria

A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD

LUCAS (Lucentis Compared to Avastin Study)

Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration