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NCT03345082 Clinical Trial

A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:
A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03345082
Other study ID # OPT-302-1002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 6, 2017
Est. completion date May 14, 2019

Study information
Verified date January 2020
Source Opthea Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Recruitment information / eligibility
Status Completed
Enrollment 366
Est. completion date May 14, 2019
Est. primary completion date May 14, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD - An ETDRS BCVA score between 60 and 25 (inclusive) letters Exclusion Criteria: - Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye - Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye - Poorly controlled diabetes mellitus (defined as HbA1c>7%) - Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• OPT-302
Intravitreal injection
• ranibizumab
Intravitreal injection
Other:
• sham intravitreal injection
Sham (mock) intravitreal injection

Locations
Country Name City State
Czechia Opthea Investigational Site Hradec Králové
Czechia Opthea Investigational Site Praha
Czechia Opthea Investigational Site Praha 10
France Opthea Investigational Site Créteil
France Opthea Investigational Site Dijon
France Opthea Investigational Site Écully
France Opthea Investigational Site Paris
France Opthea Investigational Site Paris
France Opthea Investigational Site Strasbourg
Hungary Opthea Investigational Site Budapest
Hungary Opthea Investigational Site Budapest
Hungary Opthea Investigational Site Budapest
Hungary Opthea Investigational Site Nyíregyháza
Hungary Opthea Investigational Site Szeged
Israel Opthea Investigational Site Haifa
Israel Opthea Investigational Site Haifa
Israel Opthea Investigational Site Jerusalem
Israel Opthea Investigational Site Jerusalem
Israel Opthea Investigational Site Kfar Saba
Israel Opthea Investigational Site Petach Tikva
Israel Opthea Investigational Site Re?ovot
Israel Opthea Investigational Site Tel Aviv
Italy Opthea Investigational Site Bologna
Italy Opthea Investigational Site Florence
Italy Opthea Investigational Site Milan
Italy Opthea Investigational Site Milan
Italy Opthea Investigational Site Roma
Latvia Opthea Investigational Site Jelgava
Latvia Opthea Investigational Site Riga
Latvia Opthea Investigational Site Riga
Latvia Opthea Investigational Site Riga
Poland Opthea Investigational Site Bydgoszcz
Poland Opthea Investigational Site Gdansk
Poland Opthea Investigational Site Katowice
Poland Opthea Investigational Site Kraków
Poland Opthea Investigationa Site Lublin
Poland Opthea Investigational Site Lublin
Poland Opthea Investigational Site Wroclaw
Spain Opthea Investigational Site Barcelona
Spain Opthea Investigational Site Bilbao
Spain Opthea Investigational Site Madrid
Spain Opthea Investigational Site Oviedo
Spain Opthea Investigational Site Pamplona
Spain Opthea Investigational Site Santiago De Compostela
Spain Opthea Investigational Site Valencia
Spain Opthea Investigational Site Valladolid
United Kingdom Opthea Investigational Site Bristol
United Kingdom Opthea Investigational Site Frimley
United Kingdom Opthea Investigational Site Glasgow
United Kingdom Opthea Investigational Site London
United Kingdom Opthea Investigational Site Maidstone
United Kingdom Opthea Investigational Site Sheffield
United Kingdom Opthea Investigational Site Wolverhampton
United States Opthea Investigational Site Abilene Texas
United States Opthea Investigational Site Albuquerque New Mexico
United States Opthea Investigational Site Asheville North Carolina
United States Opthea Investigational Site Augusta Georgia
United States Opthea Investigational Site Austin Texas
United States Opthea Investigational Site Baltimore Maryland
United States Opthea Investigational Site Beverly Hills California
United States Opthea Investigational Site Boynton Beach Florida
United States Opthea Investigational Site Camp Hill Pennsylvania
United States Opthea Investigational Site Charlotte North Carolina
United States Opthea Investigational Site Cleveland Ohio
United States Opthea Investigational Site Colorado Springs Colorado
United States Opthea Investigational Site Columbus Ohio
United States Opthea Investigational Site Edison New Jersey
United States Opthea Investigational Site Encino California
United States Opthea Investigational Site Fairfax Virginia
United States Opthea Investigational Site Fort Myers Florida
United States Opthea Investigational Site Fort Myers Florida
United States Opthea Investigational Site Golden Colorado
United States Opthea Investigational Site Grand Rapids Michigan
United States Opthea Investigational Site Houston Texas
United States Opthea Investigational Site Kingston Pennsylvania
United States Opthea Investigational Site Ladson South Carolina
United States Opthea Investigational Site Las Vegas Nevada
United States Opthea Investigational Site Lynbrook New York
United States Opthea Investigational Site Melbourne Florida
United States Opthea Investigational Site Paducah Kentucky
United States Opthea Investigational Site Palm Desert California
United States Opthea Investigational Site Pensacola Florida
United States Opthea Investigational Site Philadelphia Pennsylvania
United States Opthea Investigational Site Phoenix Arizona
United States Opthea Investigational Site Phoenix Arizona
United States Opthea Investigational Site Portland Oregon
United States Opthea Investigational Site Redlands California
United States Opthea Investigational Site Reno Nevada
United States Opthea Investigational Site Rochester New York
United States Opthea Investigational Site Sacramento California
United States Opthea Study Site Sacramento California
United States Opthea Investigational Site Saint Petersburg Florida
United States Opthea Investigational Site San Antonio Texas
United States Opthea Investigational Site San Diego California
United States Opthea Investigational Site Santa Ana California
United States Opthea Investigational Site Santa Barbara California
United States Opthea Investigational Site Santa Maria California
United States Opthea Investigational Site Shawnee Mission Kansas
United States Opthea Investigational Site Silverdale Washington
United States Opthea Investigational Site Syracuse New York
United States Opthea Investigational Site Tallahassee Florida
United States Opthea Investigational Site Teaneck New Jersey
United States Opthea Investigational Site The Woodlands Texas
United States Opthea Investigational Site Virginia Beach Virginia
United States Opthea Investigational Site West Columbia South Carolina
United States Opthea Investigational Site Wichita Kansas
United States Opthea Investigational Site Willow Park Texas
United States Opthea Investigational Site Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
Opthea Limited

Countries where clinical trial is conducted

United States,  Czechia,  France,  Hungary,  Israel,  Italy,  Latvia,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) Baseline to Week 24
Secondary Proportion of participants gaining 15 or more ETDRS BCVA letters Baseline to Week 24
Secondary Area under the ETDRS BCVA over time curve Baseline to Week 24
Secondary Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) Baseline to Week 24
Secondary Change in intra-retinal fluid and sub-retinal fluid on SD-OCT Baseline to Week 24
Secondary Proportion of participants losing 15 or more letters (on ETDRS BCVA chart) Baseline to Week 24
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Recruiting NCT00370539 - Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD Phase 3
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Completed NCT03909425 - Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography
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Completed NCT05131646 - Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Completed NCT04537884 - Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Phase 1
Completed NCT03216538 - Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD) Phase 1/Phase 2
Completed NCT04304755 - Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD) Phase 2
Completed NCT01958918 - Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD Phase 4
Active, not recruiting NCT01918878 - Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration. Phase 4
Completed NCT01712035 - Neovascular Age-related Macular Degeneration