Neovascular Age-related Macular DegenerationNCT03679156
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
An observational study of Neovascular Age-related Macular Degeneration, run by Hospital Hietzing.
Trial summary
Purpose: To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis. Read more about this study
- Who is it for?
- Ages 66 to 98 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2016to 15 Apr 2017
- 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
- No healthy volunteers
- Older adult
Study population: Initially 55 Participants were included in the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) trial [16]. These patients received a loading dose of 3 intravitreal injections of anti-VEGF and were subsequently treated as-needed [pro re nata (PRN)] [16]. From that study population we recruited for another long term follow up visit. Of these patients 9 (16%) were excluded due to missed visits, another 14 patients (25%) died before the last study visit and 14 former participants (25%) did not approve further study participation.
Who may be able to join
- Inclusion and exclusion criteria corresponded to the criteria of the MANTA study
Who cannot join
- Inclusion and exclusion criteria corresponded to the criteria of the MANTA study
About this study
Purpose:
To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis.
Read more
Methods:
18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using spectral domain optical coherence tomography (SD-OCT).
- Being tested
- OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Patients were recruited, visual acuity and optical coherence tomography Pictures were taken
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: 93 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start30 May 2016
- Primary completion2 Nov 2016
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 18 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
- NCT03679156
- Sponsor's protocol ID
- RPE characteristics
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 20 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 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
- ClinicalTrials.gov ID
- NCT03679156
- Acronym / sponsor ID
- RPE characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- 2 Nov 2016 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 20 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 retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis.
Methods:
18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using spectral domain optical coherence tomography (SD-OCT).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 66 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Initially 55 Participants were included in the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) trial [16]. These patients received a loading dose of 3 intravitreal injections of anti-VEGF and were subsequently treated as-needed [pro re nata (PRN)] [16]. From that study population we recruited for another long term follow up visit. Of these patients 9 (16%) were excluded due to missed visits, another 14 patients (25%) died before the last study visit and 14 former participants (25%) did not approve further study participation.
Key inclusion criteria (1 listed)
- Inclusion and exclusion criteria corresponded to the criteria of the MANTA study
Key exclusion criteria (1 listed)
- Inclusion and exclusion criteria corresponded to the criteria of the MANTA study
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 |
|---|---|---|
| OCTPatients were recruited, visual acuity and optical coherence tomography Pictures were taken | Device | – |
Primary outcome
visual acuity
Time frame: 93 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 20 Sep 2018.
- Individual participant dataSharing planned: No
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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.
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 Neovascular Age-related Macular Degeneration, 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 1 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 20 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: 93 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 20 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.