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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OPT-302
ranibizumab
sham intravitreal injection
Sponsored by
Opthea Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Study Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

0.5 mg ranibizumab with 2.0 mg OPT-302

0.5 mg ranibizumab with 0.5 mg OPT-302

0.5 mg ranibizumab with sham

Arm Description

0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)

0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)

0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham

Outcomes

Primary Outcome Measures

Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2017
Last Updated
January 8, 2021
Sponsor
Opthea Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03345082
Brief Title
A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Opthea Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5 mg ranibizumab with 2.0 mg OPT-302
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
Arm Title
0.5 mg ranibizumab with 0.5 mg OPT-302
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
Arm Title
0.5 mg ranibizumab with sham
Arm Type
Sham Comparator
Arm Description
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
Intervention Type
Biological
Intervention Name(s)
OPT-302
Intervention Description
Intravitreal injection
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal injection
Intervention Type
Other
Intervention Name(s)
sham intravitreal injection
Intervention Description
Sham (mock) intravitreal injection
Primary Outcome Measure Information:
Title
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants gaining 15 or more ETDRS BCVA letters
Time Frame
Baseline to Week 24
Title
Area under the ETDRS BCVA over time curve
Time Frame
Baseline to Week 24
Title
Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)
Time Frame
Baseline to Week 24
Title
Change in intra-retinal fluid and sub-retinal fluid on SD-OCT
Time Frame
Baseline to Week 24
Title
Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Opthea Limited
Official's Role
Study Director
Facility Information:
Facility Name
Opthea Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Opthea Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Opthea Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Opthea Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Opthea Investigational Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Opthea Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Opthea Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Opthea Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
Opthea Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Opthea Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Opthea Investigational Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Opthea Investigational Site
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Opthea Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Opthea Investigational Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Opthea Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Opthea Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Opthea Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Opthea Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Opthea Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Opthea Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Opthea Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Opthea Investigational Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Opthea Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Opthea Investigational Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Opthea Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Opthea Investigational Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Opthea Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Opthea Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Opthea Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Opthea Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Opthea Investigational Site
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Opthea Investigational Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Opthea Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Opthea Investigational Site
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Opthea Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Opthea Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Opthea Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Opthea Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Opthea Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Opthea Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Opthea Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Opthea Investigational Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Opthea Investigational Site
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Opthea Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Opthea Investigational Site
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Opthea Investigational Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Opthea Investigational Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Opthea Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Opthea Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Opthea Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Opthea Investigational Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Opthea Investigational Site
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Opthea Investigational Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Opthea Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Opthea Investigational Site
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Opthea Investigational Site
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Opthea Investigational Site
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Opthea Investigational Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Opthea Investigational Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Opthea Investigational Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Opthea Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Opthea Investigational Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Opthea Investigational Site
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
Opthea Investigational Site
City
Écully
ZIP/Postal Code
69130
Country
France
Facility Name
Opthea Investigational Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Opthea Investigational Site
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Opthea Investigational Site
City
Budapest
Country
Hungary
Facility Name
Opthea Investigational Site
City
Nyíregyháza
Country
Hungary
Facility Name
Opthea Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Opthea Investigational Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Opthea Investigational Site
City
Haifa
Country
Israel
Facility Name
Opthea Investigational Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Opthea Investigational Site
City
Jerusalem
Country
Israel
Facility Name
Opthea Investigational Site
City
Kfar Saba
Country
Israel
Facility Name
Opthea Investigational Site
City
Petach Tikva
Country
Israel
Facility Name
Opthea Investigational Site
City
Reẖovot
Country
Israel
Facility Name
Opthea Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
Opthea Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Opthea Investigational Site
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Opthea Investigational Site
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Opthea Investigational Site
City
Milan
Country
Italy
Facility Name
Opthea Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Opthea Investigational Site
City
Jelgava
Country
Latvia
Facility Name
Opthea Investigational Site
City
Riga
ZIP/Postal Code
1006
Country
Latvia
Facility Name
Opthea Investigational Site
City
Riga
ZIP/Postal Code
1009
Country
Latvia
Facility Name
Opthea Investigational Site
City
Riga
Country
Latvia
Facility Name
Opthea Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
Opthea Investigational Site
City
Gdańsk
Country
Poland
Facility Name
Opthea Investigational Site
City
Katowice
Country
Poland
Facility Name
Opthea Investigational Site
City
Kraków
Country
Poland
Facility Name
Opthea Investigationa Site
City
Lublin
ZIP/Postal Code
20079
Country
Poland
Facility Name
Opthea Investigational Site
City
Lublin
Country
Poland
Facility Name
Opthea Investigational Site
City
Wrocław
Country
Poland
Facility Name
Opthea Investigational Site
City
Barcelona
Country
Spain
Facility Name
Opthea Investigational Site
City
Bilbao
Country
Spain
Facility Name
Opthea Investigational Site
City
Madrid
Country
Spain
Facility Name
Opthea Investigational Site
City
Oviedo
Country
Spain
Facility Name
Opthea Investigational Site
City
Pamplona
Country
Spain
Facility Name
Opthea Investigational Site
City
Santiago De Compostela
Country
Spain
Facility Name
Opthea Investigational Site
City
Valencia
Country
Spain
Facility Name
Opthea Investigational Site
City
Valladolid
Country
Spain
Facility Name
Opthea Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
Opthea Investigational Site
City
Frimley
Country
United Kingdom
Facility Name
Opthea Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
Opthea Investigational Site
City
London
Country
United Kingdom
Facility Name
Opthea Investigational Site
City
Maidstone
Country
United Kingdom
Facility Name
Opthea Investigational Site
City
Sheffield
Country
United Kingdom
Facility Name
Opthea Investigational Site
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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