Clinical trial NCT01942213: 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.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age Related Macular Degeneration
Keywords: Macular
Degeneration
Age related
Neovascular
Lead sponsor: Prism Vision Group
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Private practice patients referred to retinal specialist for treatment of Neovascular Age-Related Macular Degeneration

Brief summary: This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.

Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.

Detailed description: Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.

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

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age 65-90 years
* Diagnosis or 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

Primary outcomes:
measure: To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.
timeFrame: 2-3 days after injection
Secondary outcomes:
measure: To evaluate patients 2-3 days post-injection for best corrected visual acuity
timeFrame: 2-3 days post-injection
Other outcomes:
measure: To evaluate patient's pain post-injection
timeFrame: 2-3 days post-injection
Locations:
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
Study officials:
affiliation: Prism Vision Group
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: