An observational study in Pigment Epithelial Detachment, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-08-06.
Sponsored by University Hospital Muenster · Observational
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
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 58 observational studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In total 20 eyes/patients are treated and observed after inclusion diagnosis and informed consent over a period about 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are treated according to authorization of Aflibercept
Retention and improvement of visual acuity
Visual acuity after treatment completion compared to baseline
Time frame: 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
Time frame: Screening until 1 month after last injection within study eye (Month 12)
Plan to share: No
Ran from Apr 2015 to primary completion in Apr 2018, 36 months.
Of 22 observational studies under Retinal Detachment, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 36 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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