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

Opthea

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Biological: ranibizumab; Other: sham intravitreal injection; Biological: OPT-302

Study type: Interventional

Funder types: Industry

Identifiers

NCT03345082

OPT-302-1002

Details and patient eligibility

About

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.

Enrollment: 366 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

366 participants in 3 patient groups

0.5 mg ranibizumab with 2.0 mg OPT-302

Experimental group

Description:

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

Treatment:

Biological: ranibizumab

Biological: OPT-302

0.5 mg ranibizumab with 0.5 mg OPT-302

Experimental group

Description:

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

Treatment:

Biological: ranibizumab

Biological: OPT-302

0.5 mg ranibizumab with sham

Sham Comparator group

Description:

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

Treatment:

Other: sham intravitreal injection

Biological: ranibizumab