Genetic Polymorphisms in Ranibizumab Treatment in Wet Age-Related Macular Degeneration (AMD)

Russian Academy of Medical Sciences (RAMS)

Status

Unknown

Conditions

Age-Related Macular Degeneration

Treatments

Drug: Ranibizumab

Procedure: Ranibizumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01676506

GB-1000-LC

Details and patient eligibility

About

Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis) treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.