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

NCT ID: NCT01676506

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Age-Related Macular Degeneration

Keywords

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Wet AMD genetic polymorphisms Ranibizumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ranibizumab

Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.

Intervention Type DRUG

Ranibizumab Injection

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ekaterina Chikun

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariya Budzinskaya, MD, PhD

Role: STUDY_CHAIR

State Research Institute of Eye Disease of Russian Academy of Medical Sciences

Locations

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State Research Institute of Eye Disease of Russian Academy of Medical Sciences

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Ekaterina Chikun, MD

Role: CONTACT

Phone: 0079160386679

Email: [email protected]

Facility Contacts

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Mariya Budzinskaya, MD, PhD

Role: primary

Other Identifiers

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GB-1000-LC

Identifier Type: -

Identifier Source: org_study_id