Age Related Macular DegenerationPhase 3MANTANCT00710229
Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration
A Phase 3 study testing Ranibizumab and Bevacizumab in people with Age Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. 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 Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2008to Dec 2011
- 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 durg or verteprofin 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 pathologica 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.
Austria1 site, 1 recruiting
- Recruiting
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, State of Vienna, 1030
Ilse Krebs, MD, 43-17-1165 ext. 94682, Ilse.Krebs@wienkav.at
Ilse Krebs, MD
About this study
Official title: A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA)
Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ranibizumab, Bevacizumab
- Keywords
- age related macular degeneration, Ranibizumab-Lucentis, Bevacizumab-Avastin
- 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 injection
BevacizumabDrug
Also called Avastin
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required Receives: Drug: Ranibizumab |
| B | Active comparator | Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of visual acuity over time
Measured: 12 months
Secondary outcomes (1)
Adverse events retinal thickness (OCT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenanstalt Rudolfstiftung, Medical University of Vienna, Medical University of Graz, Medical University Innsbruck, Krankenhaus der Barmherzigen Brüder Linz, Universitätsaugenklinik Salzburg, Hospital Hietzing, Hanuschkrankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710229
- Sponsor's protocol ID
- EK 07-192-1007
- Acronym
- MANTA
- Status last verified
- Jun 2010
- First submitted
- 1 Jul 2008
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Krebs I, Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, Schonherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71. doi: 10.1136/bjophthalmol-2012-302391. Epub 2013 Jan 3.
PubMed 23292928
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA)
- ClinicalTrials.gov ID
- NCT00710229
- Acronym / sponsor ID
- MANTA / EK 07-192-1007
- Conditions
- Age Related Macular Degeneration
- Keywords
- age related macular degeneration, Ranibizumab-Lucentis, Bevacizumab-Avastin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Collaborators
- Krankenanstalt Rudolfstiftung, Medical University of Vienna, Medical University of Graz, Medical University Innsbruck, Krankenhaus der Barmherzigen Brüder Linz, Universitätsaugenklinik Salzburg, Hospital Hietzing, Hanuschkrankenhaus
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (estimated)
- First posted
- 4 Jul 2008 (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.
Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: RanibizumabIntravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required |
| B | Active comparator | Drug: BevacizumabIntravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins 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 durg or verteprofin 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 |
|---|---|---|
| RanibizumabAlso: Lucentisintravitreal injection | Drug | A |
| BevacizumabAlso: Avastinintravitreal injection | Drug | B |
Primary outcome
Change of visual acuity over time
Time frame: 12 months
1 secondary outcome
Adverse events retinal thickness (OCT)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- Derived from this study: PubMed 23292928Krebs I, Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, Schonherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71. doi: 10.1136/bjophthalmol-2012-302391. Epub 2013 Jan 3.
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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.
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 and Bevacizumab in people with Age Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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 9 Jun 2010. 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 Austria. 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?
Contact Ilse Krebs, MD (43-17-1165 ext. 94682, Ilse.Krebs@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of visual acuity over time (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00710229, which also lists 1 linked publication.
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 9 Jun 2010.