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| ID | Type | Description | Link |
|---|---|---|---|
| NJRetina Observational ML28942 | Other Identifier | NJRetina |
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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.
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:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving Ranibizumab | 150 Subjects diagnosed with Neovascular Age-Related Macular Degeneration receiving Ranibizumab 0.5 mg administered by intravitreal injection. | ||
| Subjects receiving Aflibercept | 150 Subjects diagnosed with Age-related Macular Degeneration receiving Aflibercept 2 mg administered by intravitreal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept. | All eyes will be evaluated 2-3 days after injection and graded in terms of (a) aqueous cells, graded subjectively on a scale of 0-4, (b) aqueous flare, graded subjectively on a scale 0-4, (c) aqueous flare graded objectively with the FM-600 Kowa flare meter and (d) vitreous haze, graded subjectively on a scale of 0-4. | 2-3 days after injection |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate patients 2-3 days post-injection for best corrected visual acuity | Best corrected visual acuity will be assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study eye chart at a starting test distance of 4 meters. | 2-3 days post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate patient's pain post-injection | Pain will be measured on a standardized pain scale; Visual Function Questionaire -25 and a 0-10 numeric pain scale. | 2-3 days post-injection |
Inclusion Criteria:
Exclusion Criteria:
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Private practice patients referred to retinal specialist for treatment of Neovascular Age-Related Macular Degeneration
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Roth, MD | Prism Vision Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NJ Retina | Edison | New Jersey | 08820 | United States |
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