Phase 4
Completed N=66
Study EvAluating Genotypes While Using Lucentis 2
Source: ClinicalTrials.gov NCT01464723 ↗Enrolled (actual)
66
Serious AEs
—
Results posted
Aug 2019
Primary outcomePrimary: To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period.
◆ Published Evidence
Established
39citations · ~3 / year
Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration.
Summary
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Linked Publications
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Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period. |
— | — |
| SECONDARY To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Who Lose Visual Acuity (Gain <0 Letters) at 4, 6 and 12 Months After Initial Treatment. |
— | — |
| SECONDARY To Determine Whether Change in Retinal Thickness is Correlated With Genotype |
— | — |
| SECONDARY To Determine the Mean Number of Injections Per Year Patients in the Study Require. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent and comply with the study assessments for the full duration of the study.
- Age > 50 years.
- Treatment naïve (study eye only) AMD patients that are determined to be candidates for ranbizumab.
- Visual acuity 20/32 to 20/230.
Exclusion Criteria
- Pregnancy
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD.
- Any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed
- Any participation in another simultaneous medical investigation or trial for AMD *Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
Data sourced from ClinicalTrials.gov (NCT01464723) and the linked publication. 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. Informational only — not medical advice.