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

Age-Related Macular Degeneration Clinical Trial

Official title:

The Impact of Genetic Polymorphisms on Ranibizumab Treatment Outcomes in Wet Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01676506
• Other study ID #: GB-1000-LC
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2012
• Last updated: August 30, 2012
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: August 2012
• Source: Russian Academy of Medical Sciences
• Contact: Ekaterina Chikun, MD
• Phone: 0079160386679
• Email: kate_chi[@]inbox.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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

Procedure:
• Ranibizumab Injection

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Eye Disease of Russian Academy of Medical Sciences	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.	Baseline and month 3	No