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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01676506
Recruitment Status : Unknown
Verified August 2012 by Ekaterina Chikun, Russian Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Drug: Ranibizumab Procedure: Ranibizumab Injection

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Genetic Polymorphisms on Ranibizumab Treatment Outcomes in Wet Age-Related Macular Degeneration (AMD)
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Ranibizumab
    Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.
    Other Name: Lucentis
    Procedure: Ranibizumab Injection

Outcome Measures

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: Baseline and month 3 ]
    Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676506


Contacts
Contact: Ekaterina Chikun, MD 0079160386679 kate_chi@inbox.ru

Locations
Russian Federation
State Research Institute of Eye Disease of Russian Academy of Medical Sciences Recruiting
Moscow, Russian Federation, 119021
Contact: Mariya Budzinskaya, MD, PhD    0074992487686    m_budzinskaya@mail.ru   
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Study Chair: Mariya Budzinskaya, MD, PhD State Research Institute of Eye Disease of Russian Academy of Medical Sciences
More Information

Responsible Party: Ekaterina Chikun, Researcher, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01676506     History of Changes
Other Study ID Numbers: GB-1000-LC
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Ekaterina Chikun, Russian Academy of Medical Sciences:
Wet AMD
genetic polymorphisms
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents