Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

NCT02140151 | Completed Phase 1

• 1 other identifier: ML29258
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).

Conditions

Age-related Macular Degeneration

Keywords

amd; non-exudative macular degeneration; exudative macular degeneration; age-related macular degeneration; ranibizumab; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Development of exudative AMD

  Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT)

  2 years

Secondary Outcomes (7)

• Vision change

  2 years

• Vision loss

  2 years

• Number of injections

  2 years

• Baseline predictive factors

  2 years

• Development of geographic atrophy (GA)

  2 years

Study Arms (2)

Sham

NO INTERVENTION

Sham Injection

Quarterly Ranibizumab 0.5mg

ACTIVE COMPARATOR

Quarterly intravitreal injection of 0.5mg ranibizumab

Drug: Ranibizumab 0.5mg

Interventions

Ranibizumab 0.5mg DRUG

Also known as: Lucentis

Quarterly Ranibizumab 0.5mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult over 50 years old
• Able to sign informed consent and comply with the study protocol for the duration of two years
• Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
• History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment

You may not qualify if:

• Participation in another simultaneous medical investigation or clinical trial
• Patient is pregnant, lactating, or premenopausal and not using adequate contraception
• Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
• Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
• History of vitrectomy in the study eye
• History of cataract surgery within 3 months of enrollment
• History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
• History of intraocular or periocular corticosteroid therapy within the past 90 days
• History of therapeutic radiation in the region of the study eye.
• Presence of media opacity that would preclude adequate examination and/or imaging
• Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
• Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
• Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
• Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
• Concurrent use of systemic anti-VEGF therapy

Sponsors & Collaborators

• Southern California Desert Retina Consultants, MC: lead

Study Sites (4)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Southern California Desert Retina Consultants

Palm Desert, California, 92211, United States

Location

Elman Retina

Baltimore, Maryland, 21237, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Glycogen Storage Disease Type II; Wet Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glycogen Storage Disease; Carbohydrate Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Maziar Lalezary, MD

  Southern California Desert Retina Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 16, 2014
• Study Start: September 17, 2014
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

US (4)