Clinical trial NCT03397264: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Opthea Limited
Sponsor class: INDUSTRY
First posted: 2018-01-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1b - sequential dose followed by Phase 2a - parallel arm
Primary purpose: TREATMENT

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.

Detailed description: Study OPT-302-1003 was designed as a 2-part, multicenter study consisting of a Phase 1b open-label, sequential dose escalation followed by a Phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal OPT-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Baseline to Week 12
measure: Phase 2a: Response Rate Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean Change in BCVA
timeFrame: Baseline to Week 12
measure: Mean Change in CST
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Opthea Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: Opthea Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Opthea Investigational Site
state: California
city: Redlands
country: United States
facility: Opthea Investigational Site
state: California
city: Sacramento
country: United States
facility: Opthea Investigational Site
state: California
city: Santa Ana
country: United States
facility: Opthea Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Opthea Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: Opthea Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Opthea Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Opthea Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Opthea Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Opthea Investigational Site
state: Florida
city: Augusta
country: United States
facility: Opthea Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Opthea Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Opthea Investigational Site
state: Iowa
city: Wichita
country: United States
facility: Opthea Investigational Site
state: Kansas
city: Hagerstown
country: United States
facility: Opthea Investigational Site
state: Maryland
city: Las Vegas
country: United States
facility: Opthea Investigational Site
state: Nevada
city: Reno
country: United States
facility: Opthea Investigational Site
state: Nevada
city: Asheville
country: United States
facility: Opthea Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Opthea Investigational Site
state: North Carolina
city: Youngstown
country: United States
facility: Opthea Investigational Site
state: Ohio
city: Portland
country: United States
facility: Opthea Investigational Site
state: Oregon
city: Charleston
country: United States
facility: Opthea Investigational Site
state: South Carolina
city: West Columbia
country: United States
facility: Opthea Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Opthea Investigational Site
state: South Dakota
city: Germantown
country: United States
facility: Opthea Investigational Site
state: Tennessee
city: Abilene
country: United States
facility: Opthea Investigational Site
state: Texas
city: Arlington
country: United States
facility: Opthea Investigational Site
state: Texas
city: Austin
country: United States
facility: Opthea Investigational Site
state: Texas
city: Houston
country: United States
facility: Opthea Investigational Site
state: Texas
city: McAllen
country: United States
facility: Opthea Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Opthea Investigational Site
state: Texas
city: Willow Park
country: United States
facility: Opthea Investigational Site
state: Texas
city: Parramatta
country: Australia
facility: Opthea Investigational Site
state: New South Wales
city: Sydney
country: Australia
facility: Opthea Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Opthea Investigational Site
state: New South Wales
city: Perth
country: Australia
facility: Opthea Investigational Site
state: Western Australia
city: Be'er Ya'aqov
country: Israel
facility: Opthea Investigational Site
city: Haifa
country: Israel
facility: Opthea Investigational Site
city: Haifa
country: Israel
facility: Opthea Investigational Site
city: Haifa
country: Israel
facility: Opthea Investigational Site
city: Jerusalem
country: Israel
facility: Opthea Investigational Site
city: Jerusalem
country: Israel
facility: Opthea Investigational Site
city: Kfar Saba
country: Israel
facility: Opthea Investigational Site
city: Petah Tikva
country: Israel
facility: Opthea Investigational Site
city: Reẖovot
country: Israel
facility: Opthea Investigational Site
city: Tel Aviv Yafo
country: Israel
facility: Opthea Investigational Site
city: Tiberias
country: Israel
facility: Opthea Investigational Site
city: Jelgava
country: Latvia
facility: Opthea Investigational Site
city: Riga
country: Latvia
facility: Opthea Investigational Site
city: Riga
country: Latvia
facility: Opthea Investigational Site
city: Riga
country: Latvia
facility: Opthea Investigational Site
Study officials:
affiliation: Opthea Limited
name: Study Director Opthea
role: STUDY_DIRECTOR
References: