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

Phase 4

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: Lucentis

• Registration Number: NCT02944227
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2016-02-16
• Study Start: 2016-03-03
• Study First Submitted QC: 2016-10-23
• Study First Posted: 2016-10-25
• Primary Completion: 2017-02-16
• Study Completion: 2017-08-21
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lucentis	Lucentis	Lucentis fixed treatment

Primary Outcome Measures

Name	Time	Method
Changes of subretinal fluid (SRF)	Baseline and 6 months	Maximum diameter
Changes of a pigment epithelial detachment (PED)	Baseline and 6 months	Maximum diameter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of