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

NCT03345082 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: OPT-302-1002
• Study Type: interventional
• Target: 366
• Locations: 10 countries
• Sites: 108

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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 24

Secondary Outcomes (5)

• Proportion of participants gaining 15 or more ETDRS BCVA letters

  Baseline to Week 24

• Area under the ETDRS BCVA over time curve

  Baseline to Week 24

• Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)

  Baseline to Week 24

• Change in intra-retinal fluid and sub-retinal fluid on SD-OCT

  Baseline to Week 24

• Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)

  Baseline to Week 24

Study Arms (3)

0.5 mg ranibizumab with 2.0 mg OPT-302

EXPERIMENTAL

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

Biological: OPT-302; Biological: ranibizumab

0.5 mg ranibizumab with 0.5 mg OPT-302

EXPERIMENTAL

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

Biological: OPT-302; Biological: ranibizumab

0.5 mg ranibizumab with sham

SHAM COMPARATOR

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

Biological: ranibizumab; Other: sham intravitreal injection

Interventions

OPT-302 BIOLOGICAL

Intravitreal injection

0.5 mg ranibizumab with 0.5 mg OPT-302; 0.5 mg ranibizumab with 2.0 mg OPT-302

ranibizumab BIOLOGICAL

Intravitreal injection

Also known as: Lucentis

0.5 mg ranibizumab with 0.5 mg OPT-302; 0.5 mg ranibizumab with 2.0 mg OPT-302; 0.5 mg ranibizumab with sham

sham intravitreal injection OTHER

Sham (mock) intravitreal injection

0.5 mg ranibizumab with sham

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Opthea Limited: lead

Study Sites (108)

Opthea Investigational Site

Phoenix, Arizona, 85014, United States

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Phoenix, Arizona, 85020, United States

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Beverly Hills, California, 90211, United States

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Encino, California, 91436, United States

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Palm Desert, California, 92260, United States

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Redlands, California, 92374, United States

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Sacramento, California, 95819, United States

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Sacramento, California, 95841, United States

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San Diego, California, 94143, United States

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Santa Ana, California, 92705, United States

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Santa Barbara, California, 93103, United States

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Santa Maria, California, 93454, United States

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Colorado Springs, Colorado, 80909, United States

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Golden, Colorado, 80401, United States

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Boynton Beach, Florida, 33426, United States

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Fort Myers, Florida, 33907, United States

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Fort Myers, Florida, 33912, United States

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Melbourne, Florida, 32901, United States

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Pensacola, Florida, 32503, United States

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St. Petersburg, Florida, 33703, United States

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Tallahassee, Florida, 32308, United States

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Winter Haven, Florida, 33880, United States

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Augusta, Georgia, 30909, United States

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Shawnee Mission, Kansas, 66204, United States

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Wichita, Kansas, 67214, United States

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Paducah, Kentucky, 42001, United States

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Baltimore, Maryland, 21204, United States

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Grand Rapids, Michigan, 49546, United States

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Las Vegas, Nevada, 89144, United States

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Reno, Nevada, 89502, United States

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Edison, New Jersey, 08820, United States

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Teaneck, New Jersey, 07666, United States

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Albuquerque, New Mexico, 87109, United States

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Lynbrook, New York, 11563, United States

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Rochester, New York, 14620, United States

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Syracuse, New York, 13224, United States

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Asheville, North Carolina, 28803, United States

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Charlotte, North Carolina, 28210, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43212, United States

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Portland, Oregon, 97239, United States

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Camp Hill, Pennsylvania, 17011, United States

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Kingston, Pennsylvania, 18704, United States

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Philadelphia, Pennsylvania, 19107, United States

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Ladson, South Carolina, 29456, United States

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West Columbia, South Carolina, 29169, United States

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Abilene, Texas, 79606, United States

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Austin, Texas, 78705, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78240, United States

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The Woodlands, Texas, 77384, United States

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Willow Park, Texas, 76087, United States

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Fairfax, Virginia, 22031, United States

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Virginia Beach, Virginia, 23462, United States

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Silverdale, Washington, 98383, United States

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Hradec Králové, 50005, Czechia

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Prague, 10034, Czechia

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Prague, 12808, Czechia

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Créteil, 94010, France

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Dijon, 21079, France

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Écully, 69130, France

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Paris, 75010, France

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Paris, 75019, France

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Strasbourg, 67090, France

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Budapest, 1062, Hungary

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Budapest, 1133, Hungary

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Budapest, Hungary

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Nyíregyháza, Hungary

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Szeged, 6720, Hungary

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Haifa, 31048, Israel

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Haifa, Israel

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Jerusalem, 91031, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Bologna, 40138, Italy

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Florence, 50134, Italy

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Milan, 20157, Italy

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Milan, Italy

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Roma, 00133, Italy

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Jelgava, Latvia

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Riga, 1006, Latvia

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Riga, 1009, Latvia

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Riga, Latvia

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Bydgoszcz, Poland

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Gdansk, Poland

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Katowice, Poland

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Krakow, Poland

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Lublin, 20079, Poland

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Lublin, Poland

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Wroclaw, Poland

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Barcelona, Spain

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Bilbao, Spain

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Madrid, Spain

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Oviedo, Spain

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Pamplona, Spain

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Santiago de Compostela, Spain

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Valencia, Spain

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Valladolid, Spain

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Bristol, United Kingdom

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Frimley, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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Maidstone, United Kingdom

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Sheffield, United Kingdom

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Wolverhampton, United Kingdom

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Related Publications (1)

• Jackson TL, Slakter J, Buyse M, Wang K, Dugel PU, Wykoff CC, Boyer DS, Gerometta M, Baldwin ME, Price CF; Opthea Study Group Investigators. A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2023 Jun;130(6):588-597. doi: 10.1016/j.ophtha.2023.02.001. Epub 2023 Feb 6.

  PMID: 36754174 DERIVED

MeSH Terms

Interventions

Ranibizumab; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Opthea Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 6, 2017
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: January 12, 2021

Record last verified: 2020-01

Locations

GB (7); CZ (3); IT (5); LA (4); US (55); PL (7); FR (6); HU (5); IL (8); ES (8)