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.

Prism Vision Group

Status: Completed

Conditions: Neovascular Age Related Macular Degeneration

Study type: Observational

Funder types: Other

Identifiers

NCT01942213

NJRetina ML28942

NJRetina Observational ML28942 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 136 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

136 participants in 2 patient groups

Subjects receiving Ranibizumab

Description:

150 Subjects diagnosed with Neovascular Age-Related Macular Degeneration receiving Ranibizumab 0.5 mg administered by intravitreal injection.

Subjects receiving Aflibercept

Description:

150 Subjects diagnosed with Age-related Macular Degeneration receiving Aflibercept 2 mg administered by intravitreal injection