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

NCT02944227 | Completed Phase 4

• 1 other identifier: H-1512-107-728
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Macular Degeneration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

Study Arms (1)

Lucentis

EXPERIMENTAL

Lucentis fixed treatment

Drug: Lucentis

Interventions

Lucentis DRUG

Lucentis fixed-treatment arm

Also known as: Ranibizumab

Lucentis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 25277305 BACKGROUND

• 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.

  PMID: 24271025 BACKGROUND

• 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.

  PMID: 25103655 BACKGROUND

• 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.

  PMID: 21597485 BACKGROUND

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: October 25, 2016
• Study Start: March 3, 2016
• Primary Completion: February 16, 2017
• Study Completion: August 21, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

KR (1)