Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588948
Status:
WITHDRAWN
Last Update Posted:
2022-04-28
First Post:
2020-09-29
Brief Title:
A Pharmacokinetic stuDy of intRavitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not proceed due to funding issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRAW-2
Brief Summary:
The primary objective is to investigate and characterize the intraocular pharmacokinetics free and bound following intravitreal aflibercept injection IAI in vitrectomized and non-vitrectomized eyes with diabetic macular edema
The secondary objectives are to -
Investigate and characterize plasma concentrations free and bound following injections of intravitreal aflibercept in vitrectomized and non-vitrectomized eyes with diabetic macular edema
Correlate with changes in ocular concentration of drug over 12 months -
change in Best Corrected Visual Acuity BCVA
change in Central Retinal Thickness CRT
change in Diabetic Retinopathy Severity Scale DRSS
changes observed on Ocular coherence tomography angiography OCT-A
number of injections
Evaluate ocular and systemic safety of intravitreal aflibercept
Additional plasma and anterior chamber AC fluid cytokine analysis will be performed if sufficient samples are available
The secondary objectives are to -
Investigate and characterize plasma concentrations free and bound following injections of intravitreal aflibercept in vitrectomized and non-vitrectomized eyes with diabetic macular edema
Correlate with changes in ocular concentration of drug over 12 months -
change in Best Corrected Visual Acuity BCVA
change in Central Retinal Thickness CRT
change in Diabetic Retinopathy Severity Scale DRSS
changes observed on Ocular coherence tomography angiography OCT-A
number of injections
Evaluate ocular and systemic safety of intravitreal aflibercept
Additional plasma and anterior chamber AC fluid cytokine analysis will be performed if sufficient samples are available
Detailed Description:
Little information is known about the intraocular pharmacokinetics of intravitreal aflibercept injection in human eyes of Diabetic macular edema DME patients In addition the durability of intravitreal aflibercept injection in vitrectomized eyes is not known since individuals with a history of vitrectomy have been excluded from clinical trials in DME Although we recently conducted a prospective study the DRAW study to evaluate the intraocular pharmacokinetics of IAI in eyes with neovascular age-related macular degeneration AMD this research did not include eyes with DME There has been a paucity of studies on systemic levels of free aflibercept following intravitreal aflibercept injection in DME patients which would have implications for normal vascular hemostasis and wound repair in which vascular endothelial growth factor VEGF plays an important role The proposed research will fill in these gaps in the knowledge base for intravitreal aflibercept injection
Two arms non-vitrectomized and vitrectomized are included in the study to evaluate the effect of vitrectomy on the intraocular and systemic pharmacokinetics of intravitreal aflibercept injection A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate This sample size will allow for an initial determination of the pharmacokinetics of intravitreal aflibercept injection inside the eye and in the systemic circulation of eyes with DME
One eye per patient may be eligible In this research proposal participants will be followed for 12-month period Study eyes will receive intravitreal aflibercept at baseline and then starting at month 2 there will be no mandatory injection Subject will receive additional aflibercept on an as needed basis PRN if DME is still present AC fluid and blood draw will be performed prior to first PRN dose of intravitreal aflibercept
Study will involve following procedures bio-microscopy dilated fundoscopic exam measurement of intraocular pressure measurement of best corrected visual acuity BCVA fundus photograph optical coherence tomography OCT and OCT-Angiography OCT-A Patients will be followed monthly for 12 months
Two arms non-vitrectomized and vitrectomized are included in the study to evaluate the effect of vitrectomy on the intraocular and systemic pharmacokinetics of intravitreal aflibercept injection A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate This sample size will allow for an initial determination of the pharmacokinetics of intravitreal aflibercept injection inside the eye and in the systemic circulation of eyes with DME
One eye per patient may be eligible In this research proposal participants will be followed for 12-month period Study eyes will receive intravitreal aflibercept at baseline and then starting at month 2 there will be no mandatory injection Subject will receive additional aflibercept on an as needed basis PRN if DME is still present AC fluid and blood draw will be performed prior to first PRN dose of intravitreal aflibercept
Study will involve following procedures bio-microscopy dilated fundoscopic exam measurement of intraocular pressure measurement of best corrected visual acuity BCVA fundus photograph optical coherence tomography OCT and OCT-Angiography OCT-A Patients will be followed monthly for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VGFTe-DME-2041 | OTHER | Regeneron | None |