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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03345082

Enrollment

366

Registered

2017-11-17

Start date

2017-11-06

Completion date

2019-05-14

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

Brief summary

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.

Interventions

BIOLOGICALOPT-302

Intravitreal injection

BIOLOGICALranibizumab

Intravitreal injection

OTHERsham intravitreal injection

Sham (mock) intravitreal injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)	Baseline to Week 24

Secondary

Measure	Time frame
Proportion of participants gaining 15 or more ETDRS BCVA letters	Baseline to Week 24
Area under the ETDRS BCVA over time curve	Baseline to Week 24
Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)	Baseline to Week 24
Change in intra-retinal fluid and sub-retinal fluid on SD-OCT	Baseline to Week 24
Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)	Baseline to Week 24

Countries

Czechia, France, Hungary, Israel, Italy, Latvia, Poland, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026