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

Phase 2

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: OPT-302; Biological: ranibizumab; Other: sham intravitreal injection

• Registration Number: NCT03345082
• Lead Sponsor: Opthea Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Primary Completion: 2019-05-14
• Study Completion: 2019-05-14
• Status Verified: 2020-01
• Disposition First Submitted: 2021-01-08
• Disposition First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Disposition First Posted: 2021-01-12
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5 mg ranibizumab with 2.0 mg OPT-302	OPT-302	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 with 0.5 mg OPT-302	OPT-302	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 with sham	ranibizumab	0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
0.5 mg ranibizumab with 0.5 mg OPT-302	ranibizumab	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 with sham	sham intravitreal injection	0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
0.5 mg ranibizumab with 2.0 mg OPT-302	ranibizumab	0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)

Primary Outcome Measures

Name	Time	Method
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)	Baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)	Baseline to Week 24
Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)	Baseline to Week 24
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 intra-retinal fluid and sub-retinal fluid on SD-OCT	Baseline to Week 24

Trial Locations

Locations (3)

Opthea Investigational Site; 🇬🇧 Wolverhampton, United Kingdom

Opthea Study Site; 🇺🇸 Sacramento, California, United States

Opthea Investigationa Site; 🇵🇱 Lublin, Poland