A Phase 2 interventional study of OPT-302 and ranibizumab in Neovascular Age-related Macular Degeneration, sponsored by Opthea Limited. Completed at 108 sites in 10 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Opthea Limited · Phase 2, Interventional, and Treatment
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 366 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Opthea Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
Biological: OPT-302 · Biological: ranibizumab
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
Biological: OPT-302 · Biological: ranibizumab
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
Biological: ranibizumab · Other: sham intravitreal injection
Intravitreal injection
Intravitreal injection
Also known as: Lucentis
Sham (mock) intravitreal injection
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)
Time frame: Baseline to Week 24
Proportion of participants gaining 15 or more ETDRS BCVA letters
Time frame: Baseline to Week 24
Area under the ETDRS BCVA over time curve
Time frame: Baseline to Week 24
Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)
Time frame: Baseline to Week 24
Change in intra-retinal fluid and sub-retinal fluid on SD-OCT
Time frame: Baseline to Week 24
Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)
Time frame: Baseline to Week 24
Showing the first 100 of 108 sites across 10 countries. Choose a country and city above to see the rest.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sozinibercept
Opthea Limited