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

January 8, 2021 updated by: Opthea Limited

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hradec Králové, Czechia, 50005
        • Opthea Investigational Site
      • Praha, Czechia, 12808
        • Opthea Investigational Site
      • Praha 10, Czechia, 10034
        • Opthea Investigational Site
      • Créteil, France, 94010
        • Opthea Investigational Site
      • Dijon, France, 21079
        • Opthea Investigational Site
      • Paris, France, 75010
        • Opthea Investigational Site
      • Paris, France, 75019
        • Opthea Investigational Site
      • Strasbourg, France, 67090
        • Opthea Investigational Site
      • Écully, France, 69130
        • Opthea Investigational Site
      • Budapest, Hungary, 1062
        • Opthea Investigational Site
      • Budapest, Hungary, 1133
        • Opthea Investigational Site
      • Budapest, Hungary
        • Opthea Investigational Site
      • Nyíregyháza, Hungary
        • Opthea Investigational Site
      • Szeged, Hungary, 6720
        • Opthea Investigational Site
      • Haifa, Israel, 31048
        • Opthea Investigational Site
      • Haifa, Israel
        • Opthea Investigational Site
      • Jerusalem, Israel, 91031
        • Opthea Investigational Site
      • Jerusalem, Israel
        • Opthea Investigational Site
      • Kfar Saba, Israel
        • Opthea Investigational Site
      • Petach Tikva, Israel
        • Opthea Investigational Site
      • Reẖovot, Israel
        • Opthea Investigational Site
      • Tel Aviv, Israel
        • Opthea Investigational Site
      • Bologna, Italy, 40138
        • Opthea Investigational Site
      • Florence, Italy, 50134
        • Opthea Investigational Site
      • Milan, Italy, 20157
        • Opthea Investigational Site
      • Milan, Italy
        • Opthea Investigational Site
      • Roma, Italy, 00133
        • Opthea Investigational Site
      • Jelgava, Latvia
        • Opthea Investigational Site
      • Riga, Latvia, 1006
        • Opthea Investigational Site
      • Riga, Latvia, 1009
        • Opthea Investigational Site
      • Riga, Latvia
        • Opthea Investigational Site
      • Bydgoszcz, Poland
        • Opthea Investigational Site
      • Gdańsk, Poland
        • Opthea Investigational Site
      • Katowice, Poland
        • Opthea Investigational Site
      • Kraków, Poland
        • Opthea Investigational Site
      • Lublin, Poland, 20079
        • Opthea Investigationa Site
      • Lublin, Poland
        • Opthea Investigational Site
      • Wrocław, Poland
        • 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, Spain
        • 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 Kingdom
        • Opthea Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Opthea Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Opthea Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • Opthea Investigational Site
      • Encino, California, United States, 91436
        • Opthea Investigational Site
      • Palm Desert, California, United States, 92260
        • Opthea Investigational Site
      • Redlands, California, United States, 92374
        • Opthea Investigational Site
      • Sacramento, California, United States, 95819
        • Opthea Study Site
      • Sacramento, California, United States, 95841
        • Opthea Investigational Site
      • San Diego, California, United States, 94143
        • Opthea Investigational Site
      • Santa Ana, California, United States, 92705
        • Opthea Investigational Site
      • Santa Barbara, California, United States, 93103
        • Opthea Investigational Site
      • Santa Maria, California, United States, 93454
        • Opthea Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Opthea Investigational Site
      • Golden, Colorado, United States, 80401
        • Opthea Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Opthea Investigational Site
      • Fort Myers, Florida, United States, 33907
        • Opthea Investigational Site
      • Fort Myers, Florida, United States, 33912
        • Opthea Investigational Site
      • Melbourne, Florida, United States, 32901
        • Opthea Investigational Site
      • Pensacola, Florida, United States, 32503
        • Opthea Investigational Site
      • Saint Petersburg, Florida, United States, 33703
        • Opthea Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Opthea Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Opthea Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Opthea Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Opthea Investigational Site
      • Wichita, Kansas, United States, 67214
        • Opthea Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Opthea Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Opthea Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Opthea Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Opthea Investigational Site
      • Reno, Nevada, United States, 89502
        • Opthea Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Opthea Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • Opthea Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Opthea Investigational Site
    • New York
      • Lynbrook, New York, United States, 11563
        • Opthea Investigational Site
      • Rochester, New York, United States, 14620
        • Opthea Investigational Site
      • Syracuse, New York, United States, 13224
        • Opthea Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Opthea Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Opthea Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Opthea Investigational Site
      • Columbus, Ohio, United States, 43212
        • Opthea Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Opthea Investigational Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Opthea Investigational Site
      • Kingston, Pennsylvania, United States, 18704
        • Opthea Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Opthea Investigational Site
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Opthea Investigational Site
      • West Columbia, South Carolina, United States, 29169
        • Opthea Investigational Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Opthea Investigational Site
      • Austin, Texas, United States, 78705
        • Opthea Investigational Site
      • Houston, Texas, United States, 77030
        • Opthea Investigational Site
      • San Antonio, Texas, United States, 78240
        • Opthea Investigational Site
      • The Woodlands, Texas, United States, 77384
        • Opthea Investigational Site
      • Willow Park, Texas, United States, 76087
        • Opthea Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Opthea Investigational Site
      • Virginia Beach, Virginia, United States, 23462
        • Opthea Investigational Site
    • Washington
      • Silverdale, Washington, United States, 98383
        • Opthea Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.5 mg ranibizumab with 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
Intravitreal injection
Intravitreal injection
Other Names:
  • Lucentis
Experimental: 0.5 mg ranibizumab with 0.5 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
Intravitreal injection
Intravitreal injection
Other Names:
  • Lucentis
Sham Comparator: 0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
Intravitreal injection
Other Names:
  • Lucentis
Sham (mock) intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)
Time Frame: Baseline to Week 24
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants gaining 15 or more ETDRS BCVA letters
Time Frame: Baseline to Week 24
Baseline to Week 24
Area under the ETDRS BCVA over time curve
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in intra-retinal fluid and sub-retinal fluid on SD-OCT
Time Frame: Baseline to Week 24
Baseline to Week 24
Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Study Director, Opthea Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Actual)

May 14, 2019

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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