NCT01676506

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

January 17, 2012

Last Update Submit

August 30, 2012

Conditions

Age-Related Macular Degeneration

Keywords

Wet AMDgenetic polymorphismsRanibizumab

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

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

    Baseline and month 3

Interventions

RanibizumabDRUG

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

Also known as: Lucentis
Ranibizumab InjectionPROCEDURE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 119021, Russia

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mariya Budzinskaya, MD, PhD

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

    STUDY CHAIR

Central Study Contacts

Ekaterina Chikun, MD

CONTACT

0079160386679kate_chi@inbox.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 17, 2012

First Posted

August 31, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2015

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

RU(1)