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

Primary Purpose

Age-Related Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab Injection
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Wet AMD, genetic polymorphisms, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • State Research Institute of Eye Disease of Russian Academy of Medical SciencesRecruiting

Outcomes

Primary Outcome Measures

Visual acuity
Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2012
Last Updated
August 30, 2012
Sponsor
Russian Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01676506
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Wet AMD, genetic polymorphisms, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.
Intervention Type
Procedure
Intervention Name(s)
Ranibizumab Injection
Primary Outcome Measure Information:
Title
Visual acuity
Description
Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.
Time Frame
Baseline and month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterina Chikun, MD
Phone
0079160386679
Email
kate_chi@inbox.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariya Budzinskaya, MD, PhD
Organizational Affiliation
State Research Institute of Eye Disease of Russian Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
State Research Institute of Eye Disease of Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariya Budzinskaya, MD, PhD
Phone
0074992487686
Email
m_budzinskaya@mail.ru

12. IPD Sharing Statement

Learn more about this trial

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

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