Neovascular Age Related Macular Degeneration Clinical Trial
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
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:
- 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
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02251366 -
NVAMD Satellite Study
|
N/A | |
| Completed |
NCT00764738 -
Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
|
Phase 2/Phase 3 | |
| Unknown status |
NCT00767949 -
Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration
|
Phase 1 | |
| Completed |
NCT00383370 -
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
|
Phase 1 | |
| Completed |
NCT01678963 -
Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)
|
Phase 2 | |
| Completed |
NCT03930641 -
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
|
Phase 3 | |
| Completed |
NCT01863199 -
Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD)
|
Phase 4 | |
| Recruiting |
NCT05562947 -
A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration
|
Phase 3 | |
| Completed |
NCT04239027 -
A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration
|
Phase 3 | |
| Completed |
NCT00574093 -
Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD
|
Phase 2 | |
| Completed |
NCT00685100 -
Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone
|
Phase 3 | |
| Recruiting |
NCT00640640 -
The Effects of Bevacizumab and Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration (AMD)
|
N/A |