Vitreomacular InterfaceNCT03680326
Intravitreal Anti-vascular Endothelial Growth Factor Administration and Its Influence on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration
An observational study of Vitreomacular Interface, run by Hospital Hietzing.
Trial summary
Purpose: To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis. Read more about this study
- Who is it for?
- Ages 66 to 98 years
- Conditions the study is for
- Vitreomacular Interface
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 14 Apr 2018
- Phase
- Observational
- 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 66 to 98 years
- All sexes
- Older adult
Study population: treatment-naive patients with neovascular AMD
Who may be able to join
- diagnosis of treatment-naive neovascular AMD
Who cannot join
- any treatment with other anti-VEGF agents than Bevacizumab in the follow-up period
- any other diseases leading to macular edema
- prior vitrectomy
- uveitis
- retinal or corneal laser surgery
- high myopia (>6dpt)
- preceding eye trauma
About this study
Official title: Influence of Intravitreal Anti-vascular Endothelial Growth Factor Administration on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration
Purpose:
To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis.
Read more
Methods:
43 patients (51 eyes) with treatment naïve neovascular AMD subsequently treated with Bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. Following a loading dose of 3 monthly intravitreal anti-VEGF injections, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT).
Read the detailed description
This retrospective study included 43 treatment-naive patients (51 eyes) with neovascular AMD over the course of 12 months. Patients were treated with a loading dose of 3 initial monthly anti-VEGF injections (Bevacizumab 1.25mg in 0.05ml of solution-Avastin®) and were followed monthly until year 1. Re-treatment was performed if needed (pro re nata-PRN) as previously reported.
- Conditions
- Vitreomacular Interface
- Being tested
- OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
only OCT
| Study group | Role | What they receive |
|---|---|---|
| OCT | only optical coherence tomography and visual acuity testing at each visit, patients were recruited retrospectively, only data analysis Receives: Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
visual acuity testing was performed
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 posted21 Sep 2018
- Study start2 Feb 2015
- Primary completion22 Mar 2018
- Study completion14 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreomacular InterfaceStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Clara Wernigg, Hospital Hietzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680326
- Sponsor's protocol ID
- Interface, vitreomacular
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intravitreal Anti-vascular Endothelial Growth Factor Administration on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03680326
- Acronym / sponsor ID
- Interface, vitreomacular
- Conditions
- Vitreomacular Interface
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 14 Apr 2018 (actual)
- First posted
- 21 Sep 2018 (actual)
- 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.
Purpose:
To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis.
Methods:
43 patients (51 eyes) with treatment naïve neovascular AMD subsequently treated with Bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. Following a loading dose of 3 monthly intravitreal anti-VEGF injections, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT).
Detailed description
This retrospective study included 43 treatment-naive patients (51 eyes) with neovascular AMD over the course of 12 months. Patients were treated with a loading dose of 3 initial monthly anti-VEGF injections (Bevacizumab 1.25mg in 0.05ml of solution-Avastin®) and were followed monthly until year 1. Re-treatment was performed if needed (pro re nata-PRN) as previously reported.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT | – | Device: OCTonly optical coherence tomography and visual acuity testing at each visit, patients were recruited retrospectively, only data analysis |
Who may qualify
- Ages
- 66 to 98 years
- Sex
- All
- Age groups
- Older adult
- Study population
- treatment-naive patients with neovascular AMD
Key inclusion criteria (1 listed)
- diagnosis of treatment-naive neovascular AMD
Key exclusion criteria (7 listed)
- any treatment with other anti-VEGF agents than Bevacizumab in the follow-up period
- any other diseases leading to macular edema
- prior vitrectomy
- uveitis
- retinal or corneal laser surgery
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 |
|---|---|---|
| OCTonly OCT | Device | OCT |
Primary outcome
visual acuity
Time frame: 12 months
visual acuity testing was performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitreomacular Interface, run by Hospital Hietzing.
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 1 inclusion and 7 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 21 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual acuity (time frame: 12 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 21 Sep 2018.