Age-Related Macular Degeneration
Conditions
Keywords
Wet AMD, genetic polymorphisms, Ranibizumab
Brief summary
Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis) treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).
Detailed description
Age-Related Macular Degeneration (AMD) is a disease that affects central part of the retina, called macula, and is associated with progressive central vision loss. Moreover, AMD is known to be a leading cause of blindness in developed countries. In wet form of AMD, new abnormal blood vessels start to grow from the choroid towards the retina that leads to leakage from these vessels and, in turn, to impaired retinal structure and rapid vision loss. Genetic factors were found to be important in development of wet AMD. Our previous research showed the association between some genetic polymorphisms and the risk of wet AMD as well as with specific clinical features of the disease. At present, anti-vascular endothelial growth factor (anti-VEGF) therapy with intravitreous ranibizumab (Lucentis) is considered to be the most effective treatment for wet AMD. However, treatment outcomes may vary significantly from improved vision to no effect. The aim of this research is to study how ranibizumab treatment outcomes depend on genetic factors.
Interventions
DRUGRanibizumab
Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.
PROCEDURERanibizumab Injection
Sponsors
Russian Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be at least 50 years old * Neovascular age-related macular degeneration * CNV in the central part of the retina (macular is involved) * Active CNM (seen on fundus fluorescein angiography) * CNV activity is on one of the following: sub-retinal hemorrhage, sub-retinal lipid, documented loss of 3 lines of vision during last 3 months * Visual acuity of between 20/40 and 20/300 (ETDRS)
Exclusion criteria
* Patients under 50 years old * Patients with CNM not caused by AMD * Patients physically unable to tolerate intravenous fluorescein angiography * Patients with medically uncontrolled glaucoma * Patients with history of bronchial asthma, thrombophlebitis, polyvalent allergy, cancer * Any intraocular surgery within 3 months in the study eye * Prior retinal or vitreous surgery including vitrectomy or scleral buckling * Any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome * Individuals with physical or mental disabilities that prevent accurate vision testing * History of any laser treatment of CNV in study eye (laser photocoagulation or prior photodynamic therapy), or anti-VEGF (ranibizumab or bevacizumab) in the past 2 years in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | Baseline and month 3 | Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test. |
Countries
Russia
Contacts
Primary ContactEkaterina Chikun, MD
Outcome results
None listed