Recruiting
Phase 1
Phase 2

Aflibercept

Sponsor:

Vitreous -Retina- Macula Consultants of New York

Code:

NCT03594461

Conditions

Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Aflibercept Injection

Study Details

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

Study ID

NCT03594461

Start date

Sep 11, 2018

Status verified date

Jan, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

Aflibercept Injection

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

Primary outcome measure

  • Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Sariah Ramoutar Persaud

2124526929sariahpersaud@vrmny.com

Renata Salgado

2124526965rsalgado@vrmny.com

Locations

Vitreous Retina Macula Consultants of New York

Recruiting

New York, New York, United States, 10022

Contacts

Peggy Guerrero

212-452-6965

Principal Investigator:

K.Bailey Freund, MD

More Information

Sponsor

Vitreous -Retina- Macula Consultants of New York

Last update posted

Jan 10, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vitreous -Retina- Macula Consultants of New York on 2019-01-10.