Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients.
NCT ID: NCT01942213
Last Updated: 2016-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
136 participants
OBSERVATIONAL
2013-12-31
2016-04-30
Brief Summary
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Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.
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Detailed Description
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Inclusion Criteria:
* Ability to provide written informed consent and comply with study
* Age 65-90 years
* Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Exclusion Criteria:
* Previous intraocular inflammation
* Treatment with systemic anti-inflammatory agents
* Known systemic autoimmune diseases
* Treatment with intraocular steroids in the past 3 months
* History of intraocular surgery in the past 3 months
* Age greater than 90 years
* Patients who were switched between either therapies in the past 3 months
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects receiving Ranibizumab
150 Subjects diagnosed with Neovascular Age-Related Macular Degeneration receiving Ranibizumab 0.5 mg administered by intravitreal injection.
No interventions assigned to this group
Subjects receiving Aflibercept
150 Subjects diagnosed with Age-related Macular Degeneration receiving Aflibercept 2 mg administered by intravitreal injection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 65-90 years
* Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Exclusion Criteria
* Treatment with systemic anti-inflammatory agents
* Known systemic autoimmune diseases
* Treatment with intraocular steroids in the past 3 months
* History of intraocular surgery in the past 3 months
* Age greater than 90 years
* Patients who were switched between either therapies in the past 3 months
65 Years
90 Years
ALL
No
Sponsors
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Prism Vision Group
OTHER
Responsible Party
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Principal Investigators
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Daniel Roth, MD
Role: PRINCIPAL_INVESTIGATOR
Prism Vision Group
Locations
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NJ Retina
Edison, New Jersey, United States
Countries
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Other Identifiers
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NJRetina Observational ML28942
Identifier Type: OTHER
Identifier Source: secondary_id
NJRetina ML28942
Identifier Type: -
Identifier Source: org_study_id
NCT01991730
Identifier Type: -
Identifier Source: nct_alias
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