To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD

NCT01495221 | Completed Phase 4 Results

• 1 other identifier: HOLD STUDY
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.

Conditions

AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients With no Fluid on OCT at Week 24

  No primary outcome data can be found or provided.

  24 week

• Mean Change in Visual Acuity From Baseline to Week 16

  Visual acuity was documented via BCVA at every study visit.

  Baseline to Week 16

Secondary Outcomes (2)

• Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16

  Baseline and week 16

• Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16

  Baseline and 16 weeks

Study Arms (1)

Intravitreal aflibercept

OTHER

All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.

Drug: Alfilbercept

Interventions

Alfilbercept DRUG

All patients will receive 2.0 mg intravitreal aflibercept injection.

Intravitreal aflibercept

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \> 50 years
• Choroidal neovascularization secondary to AMD
• Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS chart
• Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT following at least four anti-VEGF treatments within six months before enrollment and a maximum of 5 years of years of treatment for neovascular AMD
• Documentation of presence of subretinal fluid and/or cystoid macular edema less than 30 days since last treatment

You may not qualify if:

• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Participation in another simultaneous medical investigation or trial
• Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
• Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
• Presence of significant subfoveal fibrosis or atrophy.
• Prior treatment with intravitreal aflibercept injection
• Prior treatment with triamcinolone in the study eye within 6 months of BSL.
• Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
• Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
• 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
• Current vitreous hemorrhage in the study eye
• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
• Ocular or periocular infection

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

Location

Results Point of Contact

• Title: Jason S. Slakter, MD
• Organization: Vitreous Retina Macula Consulatants of New York

mail@vrmny.com

212-861-9797

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 7, 2018
• Results First Posted: September 7, 2018

Record last verified: 2018-08

Locations

US (1)