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

O

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: OPT-302
Biological: ranibizumab
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: OPT-302
Biological: ranibizumab
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

Trial contacts and locations

108

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Data sourced from clinicaltrials.gov

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