Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03844074
Other study ID # ONS-5010-001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1, 2018
Est. completion date August 13, 2020

Study information

Verified date May 2021
Source Outlook Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date August 13, 2020
Est. primary completion date July 23, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye - Best corrected visual acuity of 20/40 to 20/320 - Study eye must: - Have active leakage on Fluorescein Angiogram involving the fovea - Have edema involving the fovea - Be free of foveal scarring - Be free of foveal atrophy Exclusion Criteria: - Previous use of anti-VEGF or bevacizumab within 6 weeks - Previous subfoveal focal laser photocoagulation in the study eye - Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization - Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year - Active intraocular inflammation (grade trace or above) in the study eye - Current vitreous haemorrhage in the study eye - Polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA) - History of idiopathic or autoimmune-associated uveitis in either eye - Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye - Uncontrolled glaucoma in the study eye (defined as intraocular pressure =30 mmHg despite treatment with anti-glaucoma medication) - Premenopausal women not using adequate contraception - Current treatment for active systemic infection - Known allergy to any component of the study drug or history of allergy to fluorescein or indocyanine green, not amenable to treatment

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
bevacizumab
1.25 mg, intravitreal injection
ranibizumab
0.5mg, intravitreal injection

Locations

Country Name City State
Australia Clinical Site Adelaide South Australia
Australia Clinical Site Brisbane Queensland
Australia Clinical Site Essendon Victoria
Australia Clinical Site Glen Waverley Victoria
Australia Clinical Site Hobart Tasmania
Australia Clinical Site Hurstville New South Wales
Australia Clinical Site Liverpool New South Wales
Australia Clinical Site Sydney New South Wales
Australia Clinical Site Westmead New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Outlook Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity. Baseline, 11 months
Secondary Mean change in the best corrected visual acuity over time BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. Baseline, monthly to 11 months
Secondary Proportion of participants who gain at least 10 letters in the best corrected visual acuity score BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. Baseline, 11 months
Secondary Proportion of participants who gain at least 5 letters in the best corrected visual acuity score BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. Baseline, 11 months
Secondary Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity. Baseline, 11 months
Secondary Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse Baseline, 11 months
Secondary Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities 11 months, 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05984927 - NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration Phase 1/Phase 2
Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT04005352 - Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON) Phase 3
Withdrawn NCT02873351 - A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration Phase 2
Active, not recruiting NCT02802657 - Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration Phase 4
Not yet recruiting NCT02864472 - Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose Phase 4
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT01445548 - Sirolimus for Advanced Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT02035722 - Intravitreal Injections-related Anxiety Phase 2/Phase 3
Completed NCT01175395 - 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Recruiting NCT01048476 - Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration Phase 1/Phase 2
Active, not recruiting NCT01174407 - Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration N/A
Terminated NCT00712491 - Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00345176 - Age-Related Eye Disease Study 2 (AREDS2) Phase 3
Completed NCT02140151 - Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration Phase 1/Phase 2
Completed NCT02555306 - A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration Phase 1/Phase 2
Recruiting NCT04796545 - Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration N/A
Completed NCT03166202 - Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
Completed NCT01397409 - Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD) Phase 2