OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe)

Opthea

Status and phase: Terminated; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Biological: 0.5 mg ranibizumab; Procedure: Sham; Biological: 2.0 mg OPT-302

Study type: Interventional

Funder types: Industry

Identifiers

NCT04757610

OPT-302-1004

Details and patient eligibility

About

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Enrollment: 986 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Main Exclusion Criteria:

• Any previous treatment for neovascular AMD.

• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.

• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

  • additional inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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986 participants in 3 patient groups

0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302

Experimental group

Description:

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.

Treatment:

Biological: 2.0 mg OPT-302

Biological: 0.5 mg ranibizumab

0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302

Experimental group

Description:

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.

Treatment:

Biological: 2.0 mg OPT-302

Biological: 0.5 mg ranibizumab

0.5 mg ranibizumab with sham

Sham Comparator group

Description:

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.

Treatment:

Procedure: Sham

Biological: 0.5 mg ranibizumab