Diabetic Macular EdemaPhase 2DRAW-2NCT04588948
A Pharmacokinetic stuDy of intRavitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema
A Phase 2 study testing Intravitreal Aflibercept in people with Diabetic Macular Edema, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Intravitreal Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema
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
Read the 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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Intravitreal Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal AfliberceptDrug
Also called Eylea
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
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomized Eyes | Experimental | The study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate. Receives: Drug: Intravitreal Aflibercept |
| Non-Vitrectomized Eyes | Experimental | The study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate. Receives: Drug: Intravitreal Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 12 months
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
Measured: over 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Study did not proceed due to funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. 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 and have 17 study visits
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Diana Do, Stanford University
- Investigators
- David Brown, MD, Principal investigator, Retina Consultants Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588948
- Sponsor's protocol ID
- 58689
- Other IDs
- VGFTe-DME-2041
- Acronym
- DRAW-2
- Status last verified
- Apr 2022
- First submitted
- 29 Sep 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26903722Semeraro 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.
PubMed 23990705Garcia-Quintanilla L, Luaces-Rodriguez A, Gil-Martinez M, Mondelo-Garcia C, Maronas O, Mangas-Sanjuan V, Gonzalez-Barcia M, Zarra-Ferro I, Aguiar P, Otero-Espinar FJ, Fernandez-Ferreiro A. Pharmacokinetics of Intravitreal Anti-VEGF Drugs in Age-Related Macular Degeneration. Pharmaceutics. 2019 Jul 31;11(8):365. doi: 10.3390/pharmaceutics11080365.
PubMed 31370346Kakinoki 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.
PubMed 22836776Ahn 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. No abstract available.
PubMed 25737148
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04588948
- Acronym / sponsor ID
- DRAW-2 / 58689
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not proceed due to funding issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. 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 and have 17 study visits
| Arm | Type | Receives |
|---|---|---|
| Vitrectomized Eyes | Experimental | Drug: Intravitreal AfliberceptThe study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate. |
| Non-Vitrectomized Eyes | Experimental | Drug: Intravitreal AfliberceptThe study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A patient must meet the following criteria to be eligible for inclusion in the study:
- 30 patients with non-vitrectomized eyes
- 30 patients with vitrectomized eyes
- Intravitreal anti-VEGF agent 6 months before study day 0
- Intravitreal steroid administered 5 months before study day 0
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal AfliberceptAlso: EyleaTwo 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 | Drug | Non-Vitrectomized Eyes, Vitrectomized Eyes |
Primary outcome
Intravitreal Aflibercept Pharmacokinetics
Time frame: 12 months
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
3 secondary outcomes
Plasma aflibercept levels
Time frame: 12 months
Correlation of drug concentration with ophthalmic outcomes
Time frame: over 12 months
Safety Outcomes
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 26903722Al-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.
- Background: PubMed 23990705Semeraro 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.
- Background: PubMed 31370346Garcia-Quintanilla L, Luaces-Rodriguez A, Gil-Martinez M, Mondelo-Garcia C, Maronas O, Mangas-Sanjuan V, Gonzalez-Barcia M, Zarra-Ferro I, Aguiar P, Otero-Espinar FJ, Fernandez-Ferreiro A. Pharmacokinetics of Intravitreal Anti-VEGF Drugs in Age-Related Macular Degeneration. Pharmaceutics. 2019 Jul 31;11(8):365. doi: 10.3390/pharmaceutics11080365.
- Background: PubMed 22836776Kakinoki 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.
- Background: PubMed 25737148Ahn 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. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brown, MD principal investigator
Retina Consultants Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal Aflibercept in people with Diabetic Macular Edema, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravitreal Aflibercept Pharmacokinetics (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588948, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.