Intense Treatment Regimen With Intravitreal Aflibercept Injection

NCT ID: NCT03594461

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2020-06-30

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.

Conditions

Neovascular Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2mg IAI q2w

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.

Group Type: EXPERIMENTAL

Aflibercept Injection

Intervention Type: DRUG

Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy

2mg IAI q3w

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.

Group Type: EXPERIMENTAL

Aflibercept Injection

Intervention Type: DRUG

Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy

Interventions

Aflibercept Injection

Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy

Intervention Type: DRUG

Other Intervention Names

Eylea

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitreous -Retina- Macula Consultants of New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

K. Bailey Freund, MD

Role: PRINCIPAL_INVESTIGATOR

Vitreous -Retina- Macula Consultants of New York

Locations

Vitreous Retina Macula Consultants of New York

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sariah Ramoutar Persaud

Role: CONTACT

sariahpersaud@vrmny.com

2124526929

Renata Salgado

Role: CONTACT

rsalgado@vrmny.com

2124526965

Facility Contacts

Peggy Guerrero

Role: primary

212-452-6965

Other Identifiers

I-TRAP

Identifier Type: -

Identifier Source: org_study_id