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

Primary Purpose

Wet Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lucentis
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lucentis

Arm Description

Lucentis fixed treatment

Outcomes

Primary Outcome Measures

Changes of a pigment epithelial detachment (PED)
Maximum height
Changes of a pigment epithelial detachment (PED)
Maximum diameter
Changes of subretinal fluid (SRF)
Maximum height
Changes of subretinal fluid (SRF)
Maximum diameter

Secondary Outcome Measures

Change in best corrected visual acuity from baseline
Changes in subfoveal thickness (SFT) measured by optical coherence tomography (OCT) from baseline
The proportion of cases maintaining vision and also who gained ≥ 15 letters from baseline
The proportion of cases having complete resolution of SRF associated with serous pigment epithelial detachment (PED)
The proportion of cases having complete resolution of subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)
The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with serous pigment epithelial detachment (PED)
The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)
The incidence of ocular adverse events
The proportion of cases experiencing leakage from neovascular AMD lesions

Full Information

First Posted
February 16, 2016
Last Updated
April 17, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02944227
Brief Title
Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 3, 2016 (Actual)
Primary Completion Date
February 16, 2017 (Actual)
Study Completion Date
August 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis
Arm Type
Experimental
Arm Description
Lucentis fixed treatment
Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
Ranibizumab
Intervention Description
Lucentis fixed-treatment arm
Primary Outcome Measure Information:
Title
Changes of a pigment epithelial detachment (PED)
Description
Maximum height
Time Frame
Baseline and 6 months
Title
Changes of a pigment epithelial detachment (PED)
Description
Maximum diameter
Time Frame
Baseline and 6 months
Title
Changes of subretinal fluid (SRF)
Description
Maximum height
Time Frame
Baseline and 6 months
Title
Changes of subretinal fluid (SRF)
Description
Maximum diameter
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in best corrected visual acuity from baseline
Time Frame
Baseline and 6 months
Title
Changes in subfoveal thickness (SFT) measured by optical coherence tomography (OCT) from baseline
Time Frame
Baseline and 6 months
Title
The proportion of cases maintaining vision and also who gained ≥ 15 letters from baseline
Time Frame
Baseline and 6 months
Title
The proportion of cases having complete resolution of SRF associated with serous pigment epithelial detachment (PED)
Time Frame
Baseline and 6 months
Title
The proportion of cases having complete resolution of subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)
Time Frame
Baseline and 6 months
Title
The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with serous pigment epithelial detachment (PED)
Time Frame
Baseline and 6 months
Title
The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)
Time Frame
Baseline and 6 months
Title
The incidence of ocular adverse events
Time Frame
Through study completion, an average of 1 year
Title
The proportion of cases experiencing leakage from neovascular AMD lesions
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25277305
Citation
Chan CK, Abraham P, Sarraf D, Nuthi AS, Lin SG, McCannel CA. Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration. Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3.
Results Reference
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PubMed Identifier
24271025
Citation
Ersoy L, Ristau T, Kirchhof B, Liakopoulos S. Response to anti-VEGF therapy in patients with subretinal fluid and pigment epithelial detachment on spectral-domain optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2014 Jun;252(6):889-97. doi: 10.1007/s00417-013-2519-9. Epub 2013 Nov 26.
Results Reference
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PubMed Identifier
25103655
Citation
Iordanous Y, Powell AM, Mao A, Hooper PL, Eng KT, Schwartz C, Kertes PJ, Sheidow TG. Intravitreal ranibizumab for the treatment of fibrovascular pigment epithelial detachment in age-related macular degeneration. Can J Ophthalmol. 2014 Aug;49(4):367-76. doi: 10.1016/j.jcjo.2014.05.010.
Results Reference
background
PubMed Identifier
21597485
Citation
Arora S, McKibbin M. One-year outcome after intravitreal ranibizumab for large, serous pigment epithelial detachment secondary to age-related macular degeneration. Eye (Lond). 2011 Aug;25(8):1034-8. doi: 10.1038/eye.2011.115. Epub 2011 May 20.
Results Reference
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Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration

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