Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 65 - 90 |
| Updated: | 3/26/2016 |
| Start Date: | October 2013 |
| Contact: | Daniel Roth, MD |
| Email: | rothretina@gmail.com |
| Phone: | 732-220-1600 |
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
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.
THIS IS AN OBSERVATION STUDY AND NOT AN INTERVENTIONAL STUDY AS TO ENTER THIS STUDY SUBJECTS
WILL HAVE HAD TO RECEIVED EITHER RANIBIZUMAB 0.5 MG OR AFIBERCEPT 2MG PRIOR TO ENTERING THE
STUDY AND SIGNING CONSENT. THIS STUDY IS TO OBSERVE THE SUBJECT POST-INJECTION RECEIVED
BEFORE ENTERING THIS STUDY.
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.
THIS IS AN OBSERVATION STUDY AND NOT AN INTERVENTIONAL STUDY AS TO ENTER THIS STUDY SUBJECTS
WILL HAVE HAD TO RECEIVED EITHER RANIBIZUMAB 0.5 MG OR AFIBERCEPT 2MG PRIOR TO ENTERING THE
STUDY AND SIGNING CONSENT. THIS STUDY IS TO OBSERVE THE SUBJECT POST-INJECTION RECEIVED
BEFORE ENTERING THIS STUDY.
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.
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 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
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