Neovascular Age-related Macular DegenerationNCT01027468
Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration
A study testing Bevacizumab in people with Neovascular Age-related Macular Degeneration, run by Medical University of Vienna.
Trial summary
200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- any subtype of neovascular age-related macular degeneration
- age of 50 years or older
- initial treatment with intravitreal bevacizumab between August 2005 and June 2006
Who cannot join
- previous vitrectomy
- presence of cystoid macular edema without choroidal neovascularization
- Uncontrolled systemic disease
About this study
Official title: Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).
Read the detailed description
In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.
- Being tested
- Bevacizumab
- Keywords
- bevacizumab, choroidal neovascularization
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called intraocular injection
intraocular bevacizumab injection
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | bevacizumab intravitreal injection Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision
Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
Measured: 3 years after first intravitreal bevacizumab treatment
CRT (Central Retinal Thickness)
Central retinal thickness measured in µm
Measured: 3 years after initial intravitreal bevacizumab treatment
Secondary outcomes (1)
Systemic Complications After Treatment
Measured: 3 years after initial bevacizumab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sacu, Medical University of Vienna
- Investigators
- Stefan Sacu, PD Dr., Principal investigator, Department of Ophthalmology, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027468
- Sponsor's protocol ID
- EK 548/2009
- Status last verified
- Apr 2019
- First submitted
- 7 Dec 2009
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
- ClinicalTrials.gov ID
- NCT01027468
- Acronym / sponsor ID
- EK 548/2009
- Keywords
- bevacizumab, choroidal neovascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2009 (estimated)
- Results
- Posted 20 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).
Detailed description
In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Bevacizumabbevacizumab intravitreal injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- any subtype of neovascular age-related macular degeneration
- age of 50 years or older
- initial treatment with intravitreal bevacizumab between August 2005 and June 2006
Key exclusion criteria (3 listed)
- previous vitrectomy
- presence of cystoid macular edema without choroidal neovascularization
- Uncontrolled systemic disease
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 |
|---|---|---|
| BevacizumabAlso: intraocular injectionintraocular bevacizumab injection | Drug | group 1 |
Primary outcome
Vision
Time frame: 3 years after first intravitreal bevacizumab treatment
Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
CRT (Central Retinal Thickness)
Time frame: 3 years after initial intravitreal bevacizumab treatment
Central retinal thickness measured in µm
1 secondary outcome
Systemic Complications After Treatment
Time frame: 3 years after initial bevacizumab treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stefan Sacu, PD Dr. principal investigator
Department of Ophthalmology, Medical University of Vienna, Austria
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab in people with Neovascular Age-related Macular Degeneration, run by Medical University of Vienna.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 3 years after first intravitreal bevacizumab treatment). The study lists 2 primary outcomes in all. 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 24 Apr 2019.