A Phase 4 interventional study of Intravitreal Aflibercept Injection 2mg in Neovascular Age-related Macular Degeneration, sponsored by Tennessee Retina. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Tennessee Retina · Phase 4, Interventional, and Treatment
This study is designed to evaluate the safety and efficacy of every 2 week intravitreal aflibercept injections in a population of neovascular AMD patients that have demonstrated refractory subretinal fluid with or without intraretinal fluid despite prior monthly intravitreal aflibercept treatment.
Eligible patients will be scheduled to receive intravitreal aflibercept (2.0mg) injections for six consecutive 2 week (13-15 days) intervals with injections administered at weeks 0, 2, 4, 6, 8, 10, and 12. The primary endpoint visit to assess response to sustained q2week therapy will be at the week 14 visit. No treatment will be administered at this visit. All patients will then return at week 16 for the randomization visit and receive a repeat intravitreal aflibercept (2.0mg) injection. For purposes of randomization, patients will be separated into the following groups:
The "q2 week complete responders" will subsequently be transitioned to a treat and extend regimen with a minimum inter-treatment interval of 4 weeks through week 24. The "q2 week incomplete responders" will be randomized in a 1:1 fashion into one of two arms:
Beginning in week 24, all patients (all groups) will undergo treatment delivered on a treat-and-extend basis with a minimum inter-treatment interval of 4 weeks through the week 50. Patient visits will be treated no more frequent than q4 weeks during treat-and-extend portions of the protocol.
All patients will have a mandatory study termination visit at week 52 (-1/+2 weeks). No study treatment will be administered after week 50. Patients receiving a study treatment after week 48 will return 4 weeks after this final study treatment for study termination visit. Patients receiving a study treatment at or before week 48 in whom the treat-and-extend protocol would dictate a subsequent visit after week 52 will instead return at week 52 for a study termination visit.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 22 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Tennessee Retina is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Demonstration of definite improvement in overall retinal thickness and/or subretinal fluid on OCT based on evaluation of examining investigator at screening visit (week -2) 13-15 days following most recent standard of care visit
o Note: screening OCT will be performed prior to dilation to allow for undilated ETDRS BCVA testing following confirmation of eligibility
Ocular Exclusion Criteria:
Systemic Exclusion Criteria
Sexually active men* or women of ** who are unwilling to practice adequate prior to the initial dose administration (baseline visit, week 0). Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; 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.
Will receive intravitreal aflibercept (2.0mg) injections for an additional four consecutive 2 week intervals at weeks 18, 20, 22, and 24
Drug: Intravitreal Aflibercept Injection 2mg
Will receive intravitreal aflibercept (2.0mg) injections on a treat-and-extend basis through week 24 with a minimum inter-treatment interval of q4 weeks.
Drug: Intravitreal Aflibercept Injection 2mg
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.
Also known as: Aflibercept; EYLEA®; VEGF Trap-Eye
Adverse Events
Frequency and severity of ocular and systemic adverse events
Time frame: Through Week 14
Retinal Thickness
Central Subfield Thickness on Optical Coherence Tomography
Time frame: Weeks 14, 16, 24, 52
Subretinal Fluid Height
Max subretinal fluid height week on Optical Coherence Tomography
Time frame: Weeks 14, 16, 24, 52
Pigment Epithelial Detachment Height
Max pigment epithelial detachment height on Optical Coherence Tomography
Time frame: Weeks 14, 16, 24, 52
Proportion of Dry Maculas
Proportion of eyes with a dry macula (no subretinal fluid on Optical Coherence Tomography)
Time frame: Weeks 14, 16, 24, 52
Best-Corrected Visual Acuity
Mean best-corrected visual acuity
Time frame: Weeks 14, 24, and 52
Change in Best-Corrected Visual Acuity
Mean change in best-corrected visual acuity from baseline
Time frame: Weeks 14, 24, and 52
Proportion gaining >5 letters of Best-Corrected Visual Acuity
Proportion of eyes gaining \> 5 letters
Time frame: Weeks 14, 24, and 52
Treatment Burden
Mean number of injections administered
Time frame: Through Week 52
Ability to Extend Treatment Interval
Proportion of eyes able to be extended during treat-and-extend dosing
Time frame: Through Week 52
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2018; primary completion for Oct 2018, 6 months later.
Of 45 phase 4 interventional studies under Macular Degeneration, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. 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