Pigment Epithelial DetachmentNCT03370380
Aflibercept in Patients With Pigment Epithelial Detachments (PED)
An observational study of Pigment Epithelial Detachment, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigment epithelial detachment secondary to AMD Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pigment Epithelial Detachment
- What is being tested?
- Aflibercept
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 17 Apr 2015to 23 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 50 years and older
- All sexes
- Adult, Older adult
Study population: In total 20 eyes/patients are treated and observed after inclusion diagnosis and informed consent over a period about 1 year.
Who may be able to join
- Patients with vascular PED due to AMD
- Male or female patients with the age > 50 years
- Angiographic and via OCT ensured PED ≥ 200 µm in the eye for treatment
- Written informed consent
- Best corrected visual acuity (ETDRS-Visus): 24 - 73 letters within
Who cannot join
- Patients that do not fulfill the a. m. inclusion criteria
- Patients which have been treated with steroids or with verteporfin via photodynamic therapy or focal lasercoagulation treatment until 3 months before,
- Anti VEGF therapy until 1 month before screening
- Patients with other retinal vascular diseases including diabetic rethinopathia or retinal vein occlusion
- Other ocular operative procedurs 3 months before Screening
- Anamnesis of non controlled glaucoma
Show all 17Show fewer
- Active or intraocular Inflammation or Inflammation of ocular adnexa
- Subfoveal fibrosis within study eye
- Larger surgical interventions 1 month before Screening
- Anamnesis of serious cardiovascular diseases or stroke 6 months before srceening
- Allergy of components of the study medication
- Patients which might be not compliant
- Patients participating at another clinical trial at the same time
- Pregnancy, breastfeeding, women in child-bearing years without using a safe contraception method
- Chronical alcohol- or drug abuse within the last year
- lack of capacity and/or knowledge of German language
- Neurologic disease i. e. multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)
Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigment epithelial detachment secondary to AMD
- Conditions
- Pigment Epithelial Detachment
- Being tested
- Aflibercept
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Patients are treated according to authorization of Aflibercept
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention and improvement of visual acuity
Visual acuity after treatment completion compared to baseline
Measured: Screening until 1 month after last injection within study eye (Month 12)
Height of Pigment Epithel Detachment
The height of PED after treatment completion compared to baseline
Measured: Screening until 1 month after last injection within study eye (Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start17 Apr 2015
- Primary completion23 Apr 2018
- Study completion23 Apr 2018
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 Pigment Epithelial DetachmentStudies 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
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Clemens, Dr. med., Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370380
- Sponsor's protocol ID
- AMD-PEA 14
- Status last verified
- Jul 2018
- First submitted
- 29 Nov 2017
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clemens CR, Alten F, Termuhlen J, Mihailovic N, Rosenberger F, Heiduschka P, Eter N. Prospective PED-study of intravitreal aflibercept for refractory vascularized pigment epithelium detachment due to age-related macular degeneration: morphologic characteristics of non-responders in optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2020 Jul;258(7):1411-1417. doi: 10.1007/s00417-020-04675-y. Epub 2020 Apr 18.
PubMed 32306096
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT03370380
- Acronym / sponsor ID
- AMD-PEA 14
- Conditions
- Pigment Epithelial Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 12 Dec 2017 (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.
Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigment epithelial detachment secondary to AMD
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In total 20 eyes/patients are treated and observed after inclusion diagnosis and informed consent over a period about 1 year.
Key inclusion criteria (5 listed)
- Patients with vascular PED due to AMD
- Male or female patients with the age > 50 years
- Angiographic and via OCT ensured PED ≥ 200 µm in the eye for treatment
- Written informed consent
- Best corrected visual acuity (ETDRS-Visus): 24 - 73 letters within
Key exclusion criteria (17 listed)
- Patients that do not fulfill the a. m. inclusion criteria
- Patients which have been treated with steroids or with verteporfin via photodynamic therapy or focal lasercoagulation treatment until 3 months before,
- Anti VEGF therapy until 1 month before screening
- Patients with other retinal vascular diseases including diabetic rethinopathia or retinal vein occlusion
- Other ocular operative procedurs 3 months before Screening
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 |
|---|---|---|
| AfliberceptPatients are treated according to authorization of Aflibercept | Drug | – |
Primary outcome
Retention and improvement of visual acuity
Time frame: Screening until 1 month after last injection within study eye (Month 12)
Visual acuity after treatment completion compared to baseline
Height of Pigment Epithel Detachment
Time frame: Screening until 1 month after last injection within study eye (Month 12)
The height of PED after treatment completion compared to baseline
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 6 Aug 2018.
- Derived from this study: PubMed 32306096Clemens CR, Alten F, Termuhlen J, Mihailovic N, Rosenberger F, Heiduschka P, Eter N. Prospective PED-study of intravitreal aflibercept for refractory vascularized pigment epithelium detachment due to age-related macular degeneration: morphologic characteristics of non-responders in optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2020 Jul;258(7):1411-1417. doi: 10.1007/s00417-020-04675-y. Epub 2020 Apr 18.
- 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.
Christoph Clemens, Dr. med. principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigment Epithelial Detachment, run by University Hospital Muenster at 1 site in Germany.
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 5 inclusion and 17 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 6 Aug 2018. 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 Germany. 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.
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?
Retention and improvement of visual acuity (time frame: Screening until 1 month after last injection within study eye (Month 12)). 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?
On the ClinicalTrials.gov record for NCT03370380, 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 6 Aug 2018.