Phase 2
N=56
Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
Age-related Macular Degeneration · Diabetic Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT02118831 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses — 0.45; 0.76; 0.11; 0.58 nM
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blood Sample Collection (Biological); Aflibercept (Drug); Bevacizumab (Drug); Ranibizumab (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- California Retina Consultants
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses |
0.45; 0.76; 0.11; 0.58; 1.47; 0.07 | — |
| SECONDARY Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment) |
19.2; 22.5; 17.0; 11.3; 10.6; 17.0 | — |
Summary
Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent for participation in this study
- Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection
Exclusion Criteria
- Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
- Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
- Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
- Subjects with history of vitrectomy
Data sourced from ClinicalTrials.gov (NCT02118831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.