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

NCT03397264 | Completed Phase 1 Results FDA Drug

• 1 other identifier: OPT-302-1003
• Study Type: interventional
• Target: 153
• Locations: 4 countries
• Sites: 53

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline to Week 12

• 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

  Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria

  Baseline to Week 12

Secondary Outcomes (2)

• Mean Change in BCVA

  Baseline to Week 12

• Mean Change in CST

  Baseline to Week 12

Study Arms (5)

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

EXPERIMENTAL

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

Biological: Aflibercept; Biological: OPT-302

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

EXPERIMENTAL

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

Biological: Aflibercept; Biological: OPT-302

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

EXPERIMENTAL

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

Biological: Aflibercept; Biological: OPT-302

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

EXPERIMENTAL

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

Biological: Aflibercept; Biological: OPT-302

Ph 2a: 2.0 mg aflibercept with sham

SHAM COMPARATOR

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

Biological: Aflibercept; Other: Sham intravitreal injection

Interventions

Aflibercept BIOLOGICAL

Intravitreal injection

Also known as: Eylea

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

OPT-302 BIOLOGICAL

Intravitreal Injection

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

Sham intravitreal injection OTHER

Sham (mock) intravitreal injection

Ph 2a: 2.0 mg aflibercept with sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Opthea Limited: lead

Study Sites (53)

Opthea Investigational Site

Phoenix, Arizona, 85014, United States

Location

Opthea Investigational Site

Bakersfield, California, 93309, United States

Location

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Beverly Hills, California, 90211, United States

Location

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Redlands, California, 92374, United States

Location

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Sacramento, California, 95819, United States

Location

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Santa Ana, California, 92705, United States

Location

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Colorado Springs, Colorado, 30909, United States

Location

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Boynton Beach, Florida, 33426, United States

Location

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Fort Myers, Florida, 33912, United States

Location

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Melbourne, Florida, 32901, United States

Location

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Pensacola, Florida, 32503, United States

Location

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St. Petersburg, Florida, 33711, United States

Location

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Augusta, Georgia, 30909, United States

Location

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Indianapolis, Indiana, 46290, United States

Location

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Des Moines, Iowa, 50266, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Hagerstown, Maryland, 21740, United States

Location

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Las Vegas, Nevada, 89144, United States

Location

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Reno, Nevada, 89502, United States

Location

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Asheville, North Carolina, 28803, United States

Location

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Charlotte, North Carolina, 28210, United States

Location

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Youngstown, Ohio, 92705, United States

Location

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Portland, Oregon, 97213, United States

Location

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Charleston, South Carolina, 29414, United States

Location

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West Columbia, South Carolina, 29169, United States

Location

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Rapid City, South Dakota, 57701, United States

Location

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Germantown, Tennessee, 38138, United States

Location

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Abilene, Texas, 79606, United States

Location

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Arlington, Texas, 76012, United States

Location

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Austin, Texas, 78705, United States

Location

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Houston, Texas, 77030, United States

Location

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McAllen, Texas, 78503, United States

Location

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San Antonio, Texas, 78240, United States

Location

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Willow Park, Texas, 76087, United States

Location

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Parramatta, New South Wales, Australia

Location

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Sydney, New South Wales, Australia

Location

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Westmead, New South Wales, 2145, Australia

Location

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Perth, Western Australia, Australia

Location

Opthea Investigational Site

Be’er Ya‘aqov, 703 5, Israel

Location

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Haifa, 31048, Israel

Location

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Haifa, 31096, Israel

Location

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Haifa, 34362, Israel

Location

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Jerusalem, 91031, Israel

Location

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Jerusalem, 91120, Israel

Location

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Kfar Saba, 44281, Israel

Location

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Petah Tikva, 49100, Israel

Location

Opthea Investigational Site

Rehovot, 76100, Israel

Location

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Tel Aviv, 64239, Israel

Location

Opthea Investigational Site

Tiberias, 15208, Israel

Location

Opthea Investigational Site

Jelgava, LV-3001, Latvia

Location

Opthea Investigational Site

Riga, LV-1002, Latvia

Location

Opthea Investigational Site

Riga, LV-1006, Latvia

Location

Opthea Investigational Site

Riga, LV-1050, Latvia

Location

MeSH Terms

Interventions

aflibercept; salicylhydroxamic acid

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Opthea

info@opthea.com

+61 3 9826 0399

Study Officials

• Study Director Opthea

  Opthea Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ph 1b open label; Ph 2a quadruple masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b - sequential dose followed by Phase 2a - parallel arm

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 11, 2018
• Study Start: January 16, 2018
• Primary Completion: March 26, 2020
• Study Completion: June 11, 2020
• Last Updated: April 22, 2025
• Results First Posted: June 22, 2022

Record last verified: 2025-04

Locations

US (34); IL (11); LA (4); AU (4)