A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: bevacizumab ONS-5010 |
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Names:
|
Active Comparator: ranibizumab
|
Biological: ranibizumab
0.5mg, intravitreal injection
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA) [Baseline, 11 months]
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.
Secondary Outcome Measures
- Mean change in the best corrected visual acuity [Baseline, monthly to 11 months]
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
- Proportion of participants who gain at least 10 letters in the best corrected visual acuity [Baseline, 11 months]
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
- Proportion of participants who gain at least 5 letters in the best corrected visual acuity [Baseline, 11 months]
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
- Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity [Baseline, 11 months]
BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
- Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [Baseline, 11 months]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
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Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen equivalent)
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Study eye must:
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Have active leakage on Fluorescein Angiogram involving the fovea
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Have edema involving the fovea
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Be free of scarring, fibrosis, or atrophy involving the central foveal zone
Exclusion Criteria:
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Previous subfoveal focal laser photocoagulation in the study eye
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Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
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Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
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Active intraocular inflammation (grade trace or above) in the study eye
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Current vitreous haemorrhage in the study eye
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Polypoidal choroidal vasculopathy (PCV) in the study eye
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History of idiopathic or autoimmune-associated uveitis in either eye
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Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
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Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
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Premenopausal women not using adequate contraception
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Current treatment for active systemic infection
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Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Site | Tucson | Arizona | United States | 85710 |
2 | Clinical Site | Arcadia | California | United States | 91007 |
3 | Clinical Site | Beverly Hills | California | United States | 90211 |
4 | Clinical Site | Campbell | California | United States | 95008 |
5 | Clinical Site | Glendale | California | United States | 91203 |
6 | Clinical Site | Laguna Hills | California | United States | 92653 |
7 | Clinical Site | Long Beach | California | United States | 90807 |
8 | Clinical Site | Mountain View | California | United States | 94040 |
9 | Clinical Site | Oxnard | California | United States | 93036 |
10 | Clinical Site | Palm Desert | California | United States | 92260 |
11 | Clinical Site | Poway | California | United States | 92064 |
12 | Clinical Site | Sacramento | California | United States | 95841 |
13 | Clinical Site | Santa Maria | California | United States | 93454 |
14 | Clinical Site | Tustin | California | United States | 92780 |
15 | Clinical Site | Golden | Colorado | United States | 80401 |
16 | Clinical Site | Hamden | Connecticut | United States | 06518 |
17 | Clinical Site | Clearwater | Florida | United States | 33761 |
18 | Clinical Site | Pinellas Park | Florida | United States | 33782 |
19 | Clinical Site | Sarasota | Florida | United States | 24233 |
20 | Clinical Site | Winter Haven | Florida | United States | 33880 |
21 | Clinical Site | Augusta | Georgia | United States | 30909 |
22 | Clinical Site | Marietta | Georgia | United States | 30060 |
23 | Clinical Site | Downers Grove | Illinois | United States | 60615 |
24 | Clinical Site | Lemont | Illinois | United States | 60439 |
25 | Clinical Site | Springfield | Illinois | United States | 62704 |
26 | Clinical Site | Indianapolis | Indiana | United States | 46290 |
27 | Clinical Site | Hagerstown | Maryland | United States | 21740 |
28 | Clinical Site | Edina | Minnesota | United States | 55435 |
29 | Clinical Site | Saint Louis | Missouri | United States | 63144 |
30 | Clinical Site | Bloomfield | New Jersey | United States | 07003 |
31 | Clinical Site | Albuquerque | New Mexico | United States | 87109 |
32 | Clinical Site | New York | New York | United States | 10021 |
33 | Clinical Site | Chambersburg | Pennsylvania | United States | 17201 |
34 | Clinical Site | Monroeville | Pennsylvania | United States | 15146 |
35 | Clinical Site | Rapid City | South Dakota | United States | 57701 |
36 | Clinical Site | Germantown | Tennessee | United States | 38138 |
37 | Clinical Site | Abilene | Texas | United States | 79606 |
38 | Clinical Site | Amarillo | Texas | United States | 79106 |
39 | Clinical Site | Arlington | Texas | United States | 76012 |
40 | Clinical Site | Dallas | Texas | United States | 75231 |
41 | Clinical Site | Grapevine | Texas | United States | 76051 |
42 | Clinical Site | Houston | Texas | United States | 77030 |
43 | Clinical Site | McAllen | Texas | United States | 78503 |
44 | Clinical Site | San Antonio | Texas | United States | 78240 |
45 | Clinical Site | San Antonio | Texas | United States | 78251 |
46 | Clinical Site | The Woodlands | Texas | United States | 77384 |
47 | Clinical Site | Willow Park | Texas | United States | 76807 |
48 | Clinical Site | Salt Lake City | Utah | United States | 84107 |
49 | Clinical Site | Norfolk | Virginia | United States | 23502 |
50 | Clinical Site | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- Outlook Therapeutics, Inc.
Investigators
- Study Director: Jennifer M Kissner, PhD, Outlook Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ONS-5010-002