OPT-302 with ranibizumab for the treatment of wet AMD
Research type
Research Study
Full 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)
IRAS ID
235145
Contact name
Tim Jackson
Contact email
Sponsor organisation
Opthea Ltd
Eudract number
2017-002698-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 10 days
Research summary
Neovascular age-related macular degeneration (wet AMD) can cause loss of central vision, affecting the ability see fine details, read, or to recognise faces.
The purpose of this research study is to determine whether adding an injection of an investigational drug, OPT-302, after an injection of the approved anti-VEGF-A drug ranibizumab, is safe and effective for the treatment of wet-AMD. This new combination therapy will be compared to the standard treatment of ranibizumab administered alone. After successful screening (including review of eligibility by an independent reading centre), study participants have an equal chance of being randomised into any one of three treatment arms (1:1:1 ratio):
• 0.5 mg ranibizumab followed by 0.5 mg OPT-302 administered to the eye
• 0.5 mg ranibizumab followed by 2.0 mg OPT-302 administered to the eye
• 0.5 mg ranibizumab followed by a sham injection administered to the eye.
The first administration of study medication will occur once all assessments have been completed at the Baseline visit. Participants will then attend the study site at 4-week intervals, during which the participant will be assessed, and study medication will be administered. A final Week-24 visit will occur 4-weeks after final administration of study medication (Week-20) for assessment of vision gain and safety.
This study is sponsored by Opthea Limited and has a global target population of 351 participants (male/female), aged at least 50 years, with a current diagnosis of wet AMD, and who haven’t received any prior therapy for wet AMD in the study eye. Approximately 50 of these patients will be based in the UK across 9 hospitals.
During study visits, various eye examinations will be performed. Safety will be assessed via review of side effects, blood pressure, heart rate and analysis of urine and blood samples. Visual function will be assessed via an eye chart and a questionnaire.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0027
Date of REC Opinion
28 Feb 2018
REC opinion
Further Information Favourable Opinion