Diabetic Macular Edema Clinical Trial
— DRAW-2Official title:
A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema
Verified date | April 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A patient must meet the following criteria to be eligible for inclusion in the study: - Age > 18 years with diabetes - Diabetic macular edema (DME) with - 30 patients with non-vitrectomized eyes - 30 patients with vitrectomized eyes • Prior DME treatment allowed if - Intravitreal anti-VEGF agent 6 months before study day 0 - Intravitreal steroid administered 5 months before study day 0 - Laser photocoagulation administered 4 months before study day 0 - Phakic and pseudophakic eyes are allowed in the study. - Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures - Willing and able to comply with clinic visits and study-related procedures Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: - Presence of other retinal vascular diseases (AMD, vein occlusion) that could affect the VEGF levels within the eye - History of fluocinolone acetonide intravitreal implant - Known hypersensitivity to aflibercept - Autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye - Infectious conjunctivitis, keratitis, or endophthalmitis of either eye - Previous participation in any studies of investigational drugs within 1 month preceding Day 0 - Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study - Pregnant or breastfeeding women - Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. 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. - Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. |
Country | Name | City | State |
---|---|---|---|
United States | Byers Eye Institute | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Regeneron Pharmaceuticals |
United States,
Ahn SJ, Ahn J, Park S, Kim H, Hwang DJ, Park JH, Park JY, Chung JY, Park KH, Woo SJ. Erratum. Intraocular Pharmacokinetics of Ranibizumab in Vitrectomized Versus Nonvitrectomized Eyes. Invest Ophthalmol Vis Sci. 2015 Mar 3;56(3):1473-4. doi: 10.1167/iovs.13-13054a. — View Citation
Al-Hinai AS. Experience of intravitreal injections in a tertiary Hospital in Oman. Oman J Ophthalmol. 2015 Sep-Dec;8(3):166-70. doi: 10.4103/0974-620X.169896. — View Citation
García-Quintanilla L, Luaces-Rodríguez A, Gil-Martínez M, Mondelo-García C, Maroñas O, Mangas-Sanjuan V, González-Barcia M, Zarra-Ferro I, Aguiar P, Otero-Espinar FJ, Fernández-Ferreiro A. Pharmacokinetics of Intravitreal Anti-VEGF Drugs in Age-Related Macular Degeneration. Pharmaceutics. 2019 Jul 31;11(8). pii: E365. doi: 10.3390/pharmaceutics11080365. Review. — View Citation
Kakinoki M, Sawada O, Sawada T, Saishin Y, Kawamura H, Ohji M. Effect of vitrectomy on aqueous VEGF concentration and pharmacokinetics of bevacizumab in macaque monkeys. Invest Ophthalmol Vis Sci. 2012 Aug 24;53(9):5877-80. doi: 10.1167/iovs.12-10164. — View Citation
Semeraro F, Morescalchi F, Duse S, Parmeggiani F, Gambicorti E, Costagliola C. Aflibercept in wet AMD: specific role and optimal use. Drug Des Devel Ther. 2013 Aug 5;7:711-22. doi: 10.2147/DDDT.S40215. eCollection 2013. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intravitreal Aflibercept Pharmacokinetics | Intraocular aflibercept levels (free and bound) after intravitreal aflibercept injection.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 | 12 months | |
Secondary | Plasma aflibercept levels | • Investigate and characterize plasma concentrations (free and bound) following injections of intravitreal aflibercept in vitrectomized and non-vitrectomized eyes with diabetic macular edema | 12 months | |
Secondary | Correlation of drug concentration with ophthalmic outcomes | Correlate with changes in ocular concentration of drug
change in BCVA change in CRT change in DRSS changes observed on OCT-A number of injections |
over 12 months | |
Secondary | Safety Outcomes | Compare adverse events during the trial to the expected adverse events on the Aflibercept label to assess ocular and systemic safety of intravitreal aflibercept. | 12 months |
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