Clinical trial NCT03844074: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Official title: A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Wet Macular Degeneration
Keywords: Subfoveal Choroidal Neovascularization
Lead sponsor: Outlook Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 61
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
timeFrame: Baseline, 11 months
Secondary outcomes:
measure: Mean change in the best corrected visual acuity over time
timeFrame: Baseline, monthly to 11 months
measure: Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
timeFrame: Baseline, 11 months
measure: Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
timeFrame: Baseline, 11 months
measure: Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
timeFrame: Baseline, 11 months
measure: Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
timeFrame: Baseline, 11 months
measure: Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
timeFrame: 11 months, 12 months
Other outcomes:
Locations:
city: Hurstville
country: Australia
facility: Clinical Site
state: New South Wales
city: Liverpool
country: Australia
facility: Clinical Site
state: New South Wales
city: Sydney
country: Australia
facility: Clinical Site
state: New South Wales
city: Westmead
country: Australia
facility: Clinical Site
state: New South Wales
city: Brisbane
country: Australia
facility: Clinical Site
state: Queensland
city: Adelaide
country: Australia
facility: Clinical Site
state: South Australia
city: Hobart
country: Australia
facility: Clinical Site
state: Tasmania
city: Essendon
country: Australia
facility: Clinical Site
state: Victoria
city: Glen Waverley
country: Australia
facility: Clinical Site
state: Victoria
Study officials:
affiliation: Outlook Therapeutics, Inc.
name: Jennifer M Kissner, PhD
role: STUDY_DIRECTOR
References: