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Completed

NCT Number: NCT03345082

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Opthea Investigational Site, Hradec Králové, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPT-302

Biological

Intravitreal injection

ranibizumab

Biological

Intravitreal injection

Other names: Lucentis

Sham intravitreal injection

Other

Sham (mock) intravitreal injection

Primary outcomes

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

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Proportion of participants gaining 15 or more ETDRS BCVA letters

    Time frame: Baseline to Week 24

  2. Area under the ETDRS BCVA over time curve

    Time frame: Baseline to Week 24

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

    Time frame: Baseline to Week 24

  4. Change in intra-retinal fluid and sub-retinal fluid on SD-OCT

    Time frame: Baseline to Week 24

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

    Time frame: Baseline to Week 24

Sponsors and collaborators

Lead sponsor

Opthea Limited

Industry

Registry information

Official study title

A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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