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

Study Overview
=================
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.

Official 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)

Conditions
-----------------
Neovascular Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Biological: OPT-302
* Biological: ranibizumab
* Other: sham intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 mg ranibizumab with 2.0 mg OPT-302<br>0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml) | Biological: OPT-302<br>* Intravitreal injection<br>Biological: ranibizumab<br>* Intravitreal injection<br>* Other names: Lucentis;|
| Experimental: 0.5 mg ranibizumab with 0.5 mg OPT-302<br>0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml) | Biological: OPT-302<br>* Intravitreal injection<br>Biological: ranibizumab<br>* Intravitreal injection<br>* Other names: Lucentis;|
| Sham Comparator: 0.5 mg ranibizumab with sham<br>0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham | Biological: ranibizumab<br>* Intravitreal injection<br>* Other names: Lucentis;Other: sham intravitreal injection<br>* Sham (mock) intravitreal injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) |  | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |