Trials / Completed
CompletedNCT01942213
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.
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 136 (actual)
- Sponsor
- Prism Vision Group · Academic / Other
- Sex
- All
- Age
- 65 Years – 90 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2013-09-13
- Last updated
- 2016-06-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01942213. Inclusion in this directory is not an endorsement.