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A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Aflibercept
OPT-302
Sham intravitreal injection
Sponsored by
Opthea Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

  • History of diabetic macular edema (DME) ≤ 2 year
  • Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response
  • Three or more prior anti-VEGF-A therapy intravitreal injections
  • EDTRS BCVA score ≤ 73 and ≥ 24 letters

Exclusion Criteria:

  • Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
  • HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes
  • Any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) 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 Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site
  • Opthea Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302

Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302

Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302

Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302

Ph 2a: 2.0 mg aflibercept with sham

Arm Description

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Phase 2a: Response Rate as Defined by Proportion of Participants Receiving Combination of OPT-302 and Aflibercept Achieving at Least a 5-letter Gain in BCVA Compared to Baseline at Week 12 According to ETDRS Criteria
BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria

Secondary Outcome Measures

Mean Change in BCVA
Mean change in Best Corrected Visual Acuity (BCVA). BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Mean Change in CST
Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)

Full Information

First Posted
January 1, 2018
Last Updated
May 30, 2022
Sponsor
Opthea Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03397264
Brief Title
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
Official Title
Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
June 11, 2020 (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

5. Study Description

Brief Summary
A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase 1b - sequential dose followed by Phase 2a - parallel arm
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Ph 1b open label; Ph 2a quadruple masked
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302
Arm Type
Experimental
Arm Description
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Arm Title
Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302
Arm Type
Experimental
Arm Description
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Arm Title
Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302
Arm Type
Experimental
Arm Description
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Arm Title
Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
Arm Type
Experimental
Arm Description
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Arm Title
Ph 2a: 2.0 mg aflibercept with sham
Arm Type
Sham Comparator
Arm Description
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Intervention Type
Biological
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal injection
Intervention Type
Biological
Intervention Name(s)
OPT-302
Intervention Description
Intravitreal Injection
Intervention Type
Other
Intervention Name(s)
Sham intravitreal injection
Intervention Description
Sham (mock) intravitreal injection
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Time Frame
Baseline to Week 12
Title
Phase 2a: Response Rate as Defined by Proportion of Participants Receiving Combination of OPT-302 and Aflibercept Achieving at Least a 5-letter Gain in BCVA Compared to Baseline at Week 12 According to ETDRS Criteria
Description
BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Mean Change in BCVA
Description
Mean change in Best Corrected Visual Acuity (BCVA). BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Time Frame
Baseline to Week 12
Title
Mean Change in CST
Description
Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of diabetic macular edema (DME) ≤ 2 year Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response Three or more prior anti-VEGF-A therapy intravitreal injections EDTRS BCVA score ≤ 73 and ≥ 24 letters Exclusion Criteria: Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes Any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study
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
Bakersfield
State/Province
California
ZIP/Postal Code
93309
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
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Opthea Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
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
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
30909
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
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
33711
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
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Opthea Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
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
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
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
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
Youngstown
State/Province
Ohio
ZIP/Postal Code
92705
Country
United States
Facility Name
Opthea Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Opthea Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
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
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Opthea Investigational Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
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
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
McAllen
State/Province
Texas
ZIP/Postal Code
78503
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
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Opthea Investigational Site
City
Parramatta
State/Province
New South Wales
Country
Australia
Facility Name
Opthea Investigational Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Opthea Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Opthea Investigational Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Opthea Investigational Site
City
Be'er Ya'aqov
ZIP/Postal Code
703 5
Country
Israel
Facility Name
Opthea Investigational Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Opthea Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Opthea Investigational Site
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Opthea Investigational Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Opthea Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Opthea Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Opthea Investigational Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Opthea Investigational Site
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Opthea Investigational Site
City
Tel Aviv Yafo
ZIP/Postal Code
64239
Country
Israel
Facility Name
Opthea Investigational Site
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
Opthea Investigational Site
City
Jelgava
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Opthea Investigational Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Opthea Investigational Site
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
Opthea Investigational Site
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia

12. IPD Sharing Statement

Learn more about this trial

A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

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