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Intense Treatment Regimen With Intravitreal Aflibercept Injection (I-TRAP)

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aflibercept Injection
Sponsored by
Vitreous -Retina- Macula Consultants of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 50 years
  • Choroidal neovascularization related to age-related macular degeneration
  • Prior treatment with any anti-VEGF agent for ≥ 12 months
  • Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days
  • Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  • Monocular patients
  • Patients with a previous history of macular thermal laser or PDT
  • Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Active intraocular inflammation (grade trace or above) in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment
  • Patients on systemic anti-VEGF treatment
  • 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 amenorrheic 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.

Sites / Locations

  • Vitreous Retina Macula Consultants of New YorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2mg IAI q2w

2mg IAI q3w

Arm Description

2mg Intravitreal Aflibercept injection will be given every 2 weeks starting at baseline and then at weeks 2, 4, 6, 8, 10 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.

2mg Intravitreal Aflibercept injection will be given every 3 weeks starting at baseline and then at weeks 3, 6, 9 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.

Outcomes

Primary Outcome Measures

Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy

Secondary Outcome Measures

Mean change in BCVA from baseline to week 12
Mean change in BCVA from baseline to week 52
Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.
Mean number of injections to achieve fluid-free status and at week 12 and week 52
Incidence and severity of adverse events through week 52
Polyp size reduction or closure - compare polyp and lesion area size to baseline on Heidelberg Eye Explorer software (Tan 2015), OCTA and ICG angiography (ICGA)
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Mean change in lesion
Mean change in lesion
Number of patients whose fovea remain dry upon extending to q4w IAI at week 52
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid

Full Information

First Posted
July 9, 2018
Last Updated
January 9, 2019
Sponsor
Vitreous -Retina- Macula Consultants of New York
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1. Study Identification

Unique Protocol Identification Number
NCT03594461
Brief Title
Intense Treatment Regimen With Intravitreal Aflibercept Injection
Acronym
I-TRAP
Official Title
Intense Treatment Regimen With Intravitreal Aflibercept Injection for Refractory Neovascular Age-Related Macular Degeneration With or Without Polypoidal Choroidal Vasculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitreous -Retina- Macula Consultants of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks
Detailed Description
The development of biologic therapy targeting VEGF has been revolutionary and has lowered the rate of functional blindness in many developed countries. Modalities to treat nvAMD have been based on monthly dosing. For many patients, this modality is adequate and they can achieve a dry macula. A subset of patients can even have their treatment intervals extended. There is, however, a subset of patients with recalcitrant neovascularization for whom IAI fails to produce a dry macula even with q4w dosing. An intense dosing schedule for a short period of time could decrease fluid activity in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2mg IAI q2w
Arm Type
Experimental
Arm Description
2mg Intravitreal Aflibercept injection will be given every 2 weeks starting at baseline and then at weeks 2, 4, 6, 8, 10 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.
Arm Title
2mg IAI q3w
Arm Type
Experimental
Arm Description
2mg Intravitreal Aflibercept injection will be given every 3 weeks starting at baseline and then at weeks 3, 6, 9 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52.
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection
Other Intervention Name(s)
Eylea
Intervention Description
Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy
Primary Outcome Measure Information:
Title
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Mean change in BCVA from baseline to week 12
Time Frame
Baseline to week 12
Title
Mean change in BCVA from baseline to week 52
Time Frame
Baseline to week 52
Title
Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.
Time Frame
Baseline to week 52
Title
Mean number of injections to achieve fluid-free status and at week 12 and week 52
Time Frame
Baseline to week 52
Title
Incidence and severity of adverse events through week 52
Time Frame
Baseline to week 52
Title
Polyp size reduction or closure - compare polyp and lesion area size to baseline on Heidelberg Eye Explorer software (Tan 2015), OCTA and ICG angiography (ICGA)
Time Frame
Baseline to week 52
Title
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Time Frame
Baseline to week 12
Title
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Time Frame
Baseline to week 52
Title
Mean change in lesion
Time Frame
Baseline to week 12
Title
Mean change in lesion
Time Frame
Baseline to week 52
Title
Number of patients whose fovea remain dry upon extending to q4w IAI at week 52
Time Frame
Baseline to week 52
Title
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Time Frame
Baseline to week 12
Title
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Time Frame
Baseline to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 50 years Choroidal neovascularization related to age-related macular degeneration Prior treatment with any anti-VEGF agent for ≥ 12 months Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: Monocular patients Patients with a previous history of macular thermal laser or PDT Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease) Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye Active intraocular inflammation (grade trace or above) in the study eye History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication) History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment Patients on systemic anti-VEGF treatment 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 amenorrheic 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sariah Ramoutar Persaud
Phone
2124526929
Email
sariahpersaud@vrmny.com
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Salgado
Phone
2124526965
Email
rsalgado@vrmny.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Bailey Freund, MD
Organizational Affiliation
Vitreous -Retina- Macula Consultants of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy Guerrero
Phone
212-452-6965
First Name & Middle Initial & Last Name & Degree
K.Bailey Freund, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intense Treatment Regimen With Intravitreal Aflibercept Injection

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