Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)

Study Overview
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Brief Summary
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The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Conditions
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Choroidal Neovascularization, Age-Related Maculopathy

Intervention / Treatment
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* Drug: dexamethasone
* Biological: ranibizumab
* Other: sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD Visual Acuity between 20/40 and 20/400 in the study eye Exclusion Criteria: Any intraocular surgery within 3 months Glaucoma Cataract High eye pressure Uncontrolled systemic disease

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexamethasone and ranibizumab<br>Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. | Drug: dexamethasone<br>* Intravitreal injection of dexamethasone 700 µg at Day 1.<br>* Other names: Posurdex;Biological: ranibizumab<br>* Ranibizumab 500 µg at day -30 and Day 7-14.<br>* Other names: Lucentis®;|
| Sham Comparator: sham and ranibizumab<br>Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. | Biological: ranibizumab<br>* Ranibizumab 500 µg at day -30 and Day 7-14.<br>* Other names: Lucentis®;Other: sham<br>* Sham needle-less injection administered in the study eye at Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection Free Interval | The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye. | Week 1 to Week 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Baseline, Week 25 | 
| Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25. | Baseline, Week 25 | 
| Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25. | Screening (-Week 28), Week 25 |