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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Czechia
      • Hradec Králové, Czechia, 50005
        • Opthea Investigational Site
      • Praha, Czechia, 12808
        • Opthea Investigational Site
      • Praha 10, Czechia, 10034
        • Opthea Investigational Site
  • France
      • 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
  • Hungary
      • 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
  • Israel
      • 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
  • Italy
      • 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
  • Latvia
      • Jelgava, Latvia
        • Opthea Investigational Site
      • Riga, Latvia, 1006
        • Opthea Investigational Site
      • Riga, Latvia, 1009
        • Opthea Investigational Site
      • Riga, Latvia
        • Opthea Investigational Site
  • Poland
      • 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
  • Spain
      • 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
  • United Kingdom
      • 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
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Biological: OPT-302
Intravitreal injection
Biological: ranibizumab
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)
Biological: OPT-302
Intravitreal injection
Biological: ranibizumab
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
Biological: ranibizumab
Intravitreal injection
Other Names:
  • Lucentis
Other: sham intravitreal injection
Sham (mock) intravitreal injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Opthea Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPT-302-1002

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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