Age Related Macular DegenerationPhase 3AxL-2009NCT01014468
Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
A Phase 3 study testing Ranibizumab (Intravitreal injection) and Bevacizumab (Intravitreal injection) in people with Age Related Macular Degeneration, run by Instituto de Olhos de Goiania at 1 site in Brazil.
Trial summary
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration. 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 (Intravitreal injection) and Bevacizumab (Intravitreal injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Feb 2012
- Phase
- Phase 3
- 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
- Age ≥ 50 years
- Active primary or recurrent subfoveal lesion with CNV secondary to AMD
Who cannot join
- Prior treatment with any intravitreal drug in the study eye
- Prior treatment with verteporfin photodynamic therapy in the study eye
- Prior treatment with systemic bevacizumab
- Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
- Laser photocoagulation within 1 month before study entry in the study eye
- Previous participation in any clinical trial within 1 month before the entry of the study
Show all 12Show fewer
- Subfoveal fibrosis or atrophy in the study eye
- CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
- Retinal pigment epithelial tear involving the macula in the study eye
- Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
- Active intraocular inflammation
- Vitreous hemorrhage in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration.
Read the detailed description
We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab and had a follow-up of at least 3 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ranibizumab (Intravitreal injection), Bevacizumab (Intravitreal injection)
- Keywords
- ranibizumab, bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab (Intravitreal injection)Drug
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Bevacizumab (Intravitreal injection)Drug
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Active comparator | Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required) Receives: Drug: Ranibizumab (Intravitreal injection) |
| Bevacizumab | Active comparator | Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required) Receives: Drug: Bevacizumab (Intravitreal injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
Measured: 6 months
Secondary outcomes (1)
Ocular side effects (infection, RD, IOP rise, cataract)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionFeb 2012 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joao Nassaralla, Instituto de Olhos de Goiania
- Investigators
- João J Nassaralla, Jr, Study chair, IOG and UnB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014468
- Sponsor's protocol ID
- JJNJ - 8 - 2009
- Acronym
- AxL-2009
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01014468
- Acronym / sponsor ID
- AxL-2009 / JJNJ - 8 - 2009
- Conditions
- Age Related Macular Degeneration
- Keywords
- ranibizumab, bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2012 (estimated)
- First posted
- 17 Nov 2009 (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.
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration.
Detailed description
We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab and had a follow-up of at least 3 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Active comparator | Drug: Ranibizumab (Intravitreal injection)Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required) |
| Bevacizumab | Active comparator | Drug: Bevacizumab (Intravitreal injection)Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 years
- Active primary or recurrent subfoveal lesion with CNV secondary to AMD
Key exclusion criteria (12 listed)
- Prior treatment with any intravitreal drug in the study eye
- Prior treatment with verteporfin photodynamic therapy in the study eye
- Prior treatment with systemic bevacizumab
- Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
- Laser photocoagulation within 1 month before study entry in the study eye
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 |
|---|---|---|
| Ranibizumab (Intravitreal injection)Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly | Drug | Ranibizumab |
| Bevacizumab (Intravitreal injection)Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly | Drug | Bevacizumab |
Primary outcome
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
Time frame: 6 months
1 secondary outcome
Ocular side effects (infection, RD, IOP rise, cataract)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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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.
João J Nassaralla, Jr study chair
IOG and UnB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab (Intravitreal injection) and Bevacizumab (Intravitreal injection) in people with Age Related Macular Degeneration, run by Instituto de Olhos de Goiania at 1 site in Brazil.
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 2 inclusion and 12 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 22 Nov 2011. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP ) (time frame: 6 months). 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 22 Nov 2011.