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

April 17, 2018 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key inclusion criteria

  1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  2. Age equal to or older than 50 years.

  3. 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

  1. Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye
  2. Prior treatment with photodynamic therapy in the study eye
  3. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  4. Previous submacular surgery in the study eye
  5. History of vitrectomy in the study eye
  6. Epiretinal membranes (ERM)
  7. Submacular hemorrhage or fibrosis within 50% of entire PED.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lucentis
Lucentis fixed treatment
Drug: Lucentis
Lucentis fixed-treatment arm
Other Names:
  • Ranibizumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2016

Primary Completion (Actual)

February 16, 2017

Study Completion (Actual)

August 21, 2017

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

October 23, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1512-107-728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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