Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study

NCT01813773 | Completed Phase 2

• 1 other identifier: THE A.C.T. STUDY
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events of intravitreal aflibercept injection in the treatment of PDR.

  The primary endpoint of the study will be at week 52.

Secondary Outcomes (9)

• Mean change in the area of fluorescein leakage in mm2 (area of neovascularization) compared to baseline.

  At Weeks 24 and 52

• Proportion of subjects with complete regression of neovascularization

  At Weeks 24 and 52

• Mean change in ETDRS BCVA from baseline

  At Weeks 24 and 52

• Proportion of subjects gaining > 5 letters, > 10 letters and > 15 letters from baseline

  At Weeks 24 and 52

• Proportion of subjects losing > 5 letters from baseline

  At Weeks 24 and 52

Study Arms (2)

Group A - IAI every 4 weeks

EXPERIMENTAL

Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will continue to receive IAI every 4 weeks, beginning week 20, through week 48.

Drug: Intravitreal Aflibercept Injection (IAI)

Group B - IAI every 8 weeks

EXPERIMENTAL

Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will receive IAI every 8 weeks, beginning week 24, through week 48.

Drug: Intravitreal Aflibercept Injection (IAI)

Interventions

Intravitreal Aflibercept Injection (IAI) DRUG

EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.

Also known as: Eylea

Group A - IAI every 4 weeks; Group B - IAI every 8 weeks

Eligibility Criteria

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

You may qualify if:

• Subjects will be enrolled if the following criteria are met:
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age 18 years and older
• Retinal neovascularization secondary to diabetic retinopathy
• Best corrected visual acuity in the study eye better than 20/320 using an ETDRS chart
• In the event that either eye of a potential subject meets enrollment criteria, the worse sighted eye will be enrolled into the study. Only one eye can be enrolled in the study.

You may not qualify if:

• Pregnant or breast-feeding women Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study and for at least 30 days after the last administration of study drug for women and at least 90 days after the last administration for men (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 \[IUD\];; 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.
• \*\* Pregnancy testing and contraception are not required for women with documented hysterectomy.
• HbA1C \>10 within approximately 90 days of Screening visit
• Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
• Prior treatment with systemic anti-VEGF agents
• Presence of any substantial ocular disease (other than diabetic retinopathy) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
• Prior treatment with anti-VEGF therapy in the study eye within 90 days of baseline
• Prior treatment with PRP within 60 days
• Prior treatment with IAI.
• Prior treatment with triamcinolone in the study eye within 180 days of baseline.
• Prior treatment with dexamethasone in the study eye within 30 days prior to baseline.
• Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline
• History of vitrectomy surgery in the study eye.
• Active intraocular inflammation (grade trace or above) in the study eye

Sponsors & Collaborators

• Ophthalmic Consultants of Long Island: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Glenn L Stoller, MD

  Ophthalmic Consultants of Long Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 19, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

US (1)