Intense Treatment Regimen With Intravitreal Aflibercept Injection

NCT03594461 | Unknown Phase 1 FDA Drug

• 1 other identifier: I-TRAP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 12 weeks

Secondary Outcomes (13)

• Mean change in BCVA from baseline to week 12

  Baseline to week 12

• Mean change in BCVA from baseline to week 52

  Baseline to week 52

• Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.

  Baseline to week 52

• Mean number of injections to achieve fluid-free status and at week 12 and week 52

  Baseline to week 52

• Incidence and severity of adverse events through week 52

  Baseline to week 52

Study Arms (2)

2mg IAI q2w

EXPERIMENTAL

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.

Drug: Aflibercept Injection

2mg IAI q3w

EXPERIMENTAL

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.

Drug: Aflibercept Injection

Interventions

Aflibercept Injection DRUG

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

Also known as: Eylea

2mg IAI q2w; 2mg IAI q3w

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitreous -Retina- Macula Consultants of New York: lead

Study Sites (1)

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Interventions

aflibercept

Study Officials

• K. Bailey Freund, MD

  Vitreous -Retina- Macula Consultants of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sariah Ramoutar Persaud

CONTACT

2124526929; sariahpersaud@vrmny.com

Renata Salgado

CONTACT

2124526965; rsalgado@vrmny.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 20, 2018
• Study Start: September 11, 2018
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)