Age-Related Macular DegenerationNCT01676506
Genetic Polymorphisms in Ranibizumab Treatment in Wet Age-Related Macular Degeneration (AMD)
A study testing Ranibizumab and Ranibizumab Injection in people with Age-Related Macular Degeneration, run by Russian Academy of Medical Sciences at 1 site in Russia.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Ranibizumab and Ranibizumab Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of Eye Disease of Russian Academy of Medical Sciences
Moscow, 119021
Mariya Budzinskaya, MD, PhD, 0074992487686, m_budzinskaya@mail.ru
About this study
Official title: The Impact of Genetic Polymorphisms on Ranibizumab Treatment Outcomes in Wet Age-Related Macular Degeneration (AMD)
Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis) treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).
Read the 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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Ranibizumab, Ranibizumab Injection
- Keywords
- Wet AMD, genetic polymorphisms, Ranibizumab
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.
Ranibizumab InjectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.
Measured: Baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Chikun, Russian Academy of Medical Sciences
- Investigators
- Mariya Budzinskaya, MD, PhD, Study chair, State Research Institute of Eye Disease of Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676506
- Sponsor's protocol ID
- GB-1000-LC
- Status last verified
- Aug 2012
- First submitted
- 17 Jan 2012
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Genetic Polymorphisms on Ranibizumab Treatment Outcomes in Wet Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01676506
- Acronym / sponsor ID
- GB-1000-LC
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Wet AMD, genetic polymorphisms, Ranibizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanibizumabAlso: LucentisIntravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2. | Drug | – |
| Ranibizumab Injection | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariya Budzinskaya, MD, PhD study chair
State Research Institute of Eye Disease of Russian Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab and Ranibizumab Injection in people with Age-Related Macular Degeneration, run by Russian Academy of Medical Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Chikun, MD (0079160386679, kate_chi@inbox.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Baseline and month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.