Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.

Detailed Description
-----------------
PEDs occur in up to 62% of eyes with advanced AMD. Numerous treatment options have been employed for PEDs in AMD, including laser therapies and intravitreal injections of anti-VEGF antibodies. However, eyes with PEDs were excluded from the larger clinical trials that used macular laser, photodynamic therapy, or ranibizumab to treat neovascular AMD; therefore, the efficacy of such options is still unclear for eyes with PEDs in neovascular AMD. Additionally, PED lesions have been reported to show less morphological and functional response to anti-VEGF monotherapy than eyes with other CNV lesions subtypes. Based on the generally poor prognosis of PEDs and the lack of sufficient data in the literature regarding the effectiveness of fixed monthly dosing of Lucentis® (Ranibizumab) therapy, the investigators designed a prospective study to evaluate the effect of intensive fixed monthly dosing of Ranibizumab for the treatment of SRF associated with PED in neovascular AMD which is persistent to previous anti-VEGF monotherapy.

Official Title
-----------------
Efficacy of Fixed Monthly Dosing of Lucentis® (Ranibizumab) on Subretinal Fluid (SRF) Associated With Persistent Pigment Epithelial Detachment (PED) in Neovascular Age-related Macular Degeneration (AMD): A Pilot Study

Conditions
-----------------
Wet Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Lucentis


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age equal to or older than 50 years. Presence of SRF associated with PED in neovascular AMD (proven with OCT FA, and ICG) which is persistent despite consecutive anti-VEGF injections for at least 9 months (3 initial loading doses with 4 week interval followed by PRN regimen) A persistent PED is defined as a subject with < 50% reduction or increase in PED height Key exclusion criteria Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye Prior treatment with photodynamic therapy in the study eye Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye Previous submacular surgery in the study eye History of vitrectomy in the study eye Epiretinal membranes (ERM) Submacular hemorrhage or fibrosis within 50% of entire PED.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis<br>Lucentis fixed treatment | Drug: Lucentis<br>* Lucentis fixed-treatment arm<br>* Other names: Ranibizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of a pigment epithelial detachment (PED) | Maximum height | Baseline and 6 months | 
| Changes of a pigment epithelial detachment (PED) | Maximum diameter | Baseline and 6 months | 
| Changes of subretinal fluid (SRF) | Maximum height | Baseline and 6 months | 
| Changes of subretinal fluid (SRF) | Maximum diameter | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best corrected visual acuity from baseline |  | Baseline and 6 months | 
| Changes in subfoveal thickness (SFT) measured by optical coherence tomography (OCT) from baseline |  | Baseline and 6 months | 
| The proportion of cases maintaining vision and also who gained ≥ 15 letters from baseline |  | Baseline and 6 months | 
| The proportion of cases having complete resolution of SRF associated with serous pigment epithelial detachment (PED) |  | Baseline and 6 months | 
| The proportion of cases having complete resolution of subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED) |  | Baseline and 6 months | 
| The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with serous pigment epithelial detachment (PED) |  | Baseline and 6 months | 
| The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED) |  | Baseline and 6 months | 
| The incidence of ocular adverse events |  | Through study completion, an average of 1 year | 
| The proportion of cases experiencing leakage from neovascular AMD lesions |  | Baseline and 6 months |