Clinical trial NCT01676506: Genetic Polymorphisms in Ranibizumab Treatment in Wet Age-Related Macular Degeneration (AMD)
Official title: The Impact of Genetic Polymorphisms on Ranibizumab Treatment Outcomes in Wet Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD
genetic polymorphisms
Ranibizumab
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity
timeFrame: Baseline and month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Research Institute of Eye Disease of Russian Academy of Medical Sciences
Study officials:
affiliation: State Research Institute of Eye Disease of Russian Academy of Medical Sciences
name: Mariya Budzinskaya, MD, PhD
role: STUDY_CHAIR
References: