A Phase 4 interventional study of Aflibercept in Age Related Macular Degeneration and Pigment Epithelial Detachment, sponsored by Tennessee Retina. Status unknown at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-10-29.
Sponsored by Tennessee Retina · Phase 4, Interventional, and Treatment
Among 66 studies testing aflibercept in Macular Degeneration — 2 open to participants now, 5 under way, 2 of them phase 3. aflibercept · Macular Degeneration.
Among the 66 studies testing aflibercept in Macular Degeneration, this one is the 52nd largest by enrollment, is one of 5 that started in 2012, is one of 27 in phase 4, and was the 10th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 30 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →2 of the 66 studies testing aflibercept in Macular Degeneration are open now, in 9 countries. Each count lists the studies.
aflibercept: first FDA approval 2011 (EYLEA), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 165 Macular Degeneration studies recruiting now, 116 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →66 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2012.
Median enrollment 55 across the 66 interventional studies. Of the 48 that completed or were terminated, 28 (58%) have results posted.
31 of 66 have an industry lead sponsor. The 10 most frequent:
Tennessee Retina is the lead sponsor of 3 studies on the registry; none are open to participants now.
Tennessee Retina has 2 studies filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
2 of the studies testing aflibercept in Macular Degeneration that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07614776Phase 3AmgenA Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration | 2027-07-31 |
| NCT04932980Berner AugenklinikComparison of Rapid Aflibercept and Brolucizumab T&E in wAMD | 2027-06 |
Among the 66 studies testing aflibercept in Macular Degeneration, from their registry updates:
The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs.
A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs (the ROLL study).
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.
Previous enrollment in the study evaluating 2.0mg ranibizumab (NCT 01189019) without early study discontinuation. The last treatment* in the study eye should have been received at least 30 days before enrollment in this study.
**last study treatment of either 1.0mg or 2.0mg ranibizumab
Exclusion Criteria:
Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
Sexually active men* or women of ** who are unwilling to practice adequate during the study (adequate contraception measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam or jelly).
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.
Drug: Aflibercept
Intravitreal Injection 2mg/0.05mL Aflibercept
Also known as: VEGF-Trap, Eylea
Proportion of patients with flattening of PED
Time frame: 12 months
Mean Change in Best Corrected Visual Acuity (BCVA)
Time frame: 6 month timepoint and 12 month timepoints
Proportion of patients with flattening of PED
Time frame: 6 months
Proportion of patients with flattening of PED
Time frame: 18 month and 24 month timepoints
Mean number of injections needed
Time frame: 12 month period
Mean change in Optical Coherence Tomography (OCT) central retinal thickness
Time frame: 6 month and 12 month timepoints
Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time frame: 6 month and 12 month timepoint
Mean change in BCVA
Time frame: 18 month and 24 month timepoint
Mean number of injections
Time frame: during year 2
Mean change in OCT central retinal thickness
Time frame: 18 month and 24 month timepoints
Proportion of patients gaining 5 letters or more
Time frame: 18 month and 24 month timepoints
Incidence and severity of adverse events
Time frame: 24 month period
This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aflibercept
Tennessee Retina