Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept

NCT01617148 | Completed Phase 4 Results

• 1 other identifier: VGFTe-AMD-1211
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections. Patients will be followed for 24 months. The follow up phase will be completed at month 36.

Conditions

Exudative Macular Degeneration

Keywords

Exudative Macular Degeneration; Aflibercept

Outcome Measures

Primary Outcomes (1)

• Change in Central Subfield Thickness From Baseline at 12 Months

  The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT

  baseline and 12 months

Secondary Outcomes (7)

• Change in Best-corrected Visual Acuity From Baseline at 12 Months

  Baseline and 12 months

• Change in Macular Volume From Baseline at 12 Months.

  baseline and 12 months

• Change in Cube Average Thickness From Baseline at 12 Months

  baseline and 12 months

• Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.

  baseline and 12 months

• Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months

  baseline and 12 months

Study Arms (1)

Treatment with Aflibercept

EXPERIMENTAL

Subjects were given 2 mg (0.05 mL) of intravitreal aflibercept injection administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.

Drug: Aflibercept

Interventions

Aflibercept DRUG

Patients received 2 mg (0.05 mL) of intravitreal aflibercept injection administered monthly for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.

Treatment with Aflibercept

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent.
• Men and women ≥ 50 years of age.
• Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by historical optical coherence tomographies (OCTs) and angiograms in the study eye.
• CNV must be at least 50% of total lesion size by either previous or current angiogram.
• ETDRS best-corrected visual acuity of: 20/25 to 20/320 (letter score of 73 to 25) in the study eye.
• Willing, committed, and able to return for all clinic visits and complete all study related procedures.
• At least one injection of Ranibizumab or Bevacizumab within 3 months of enrollment for active exudative AMD.
• Active need for anti- vascular endothelial growth factor (anti-VEGF) therapy at study entry based on the following criteria:
• Presence of fluid by either optical coherence tomography (OCT) or clinical examination (further defined as intraretinal, cystoid, subretinal, worsening pigment epithelial detachment)
• Presence of new hemorrhage on clinical examination

You may not qualify if:

• A subject who meets any of the following criteria will be excluded from the study:
• Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
• Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
• Presence of retinal pigment epithelial tears or rips involving the macula in the study
• History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
• Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
• History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
• Prior vitrectomy in the study eye.
• History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
• Any history of macular hole of stage 2 and above in the study eye.
• Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
• Prior trabeculectomy or other filtration surgery in the study eye.
• Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
• Active intraocular inflammation in either eye.
• Active ocular or periocular infection in either eye.

Sponsors & Collaborators

• Rishi Singh: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Singh RP, Srivastava SK, Ehlers JP, Silva FQ, Bedi R, Schachat AP, Kaiser PK. A single-arm, investigator-initiated study of the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration previously treated with ranibizumab or bevacizumab (ASSESS study): 12-month analysis. Clin Ophthalmol. 2015 Sep 22;9:1759-66. doi: 10.2147/OPTH.S87043. eCollection 2015.

  PMID: 26445522 RESULT

• Singh RP, Srivastava S, Ehlers JP, Bedi R, Schachat AP, Kaiser PK. A single-arm, investigator-initiated study of the efficacy, safety and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration, previously treated with ranibizumab or bevacizumab: 6-month interim analysis. Br J Ophthalmol. 2014 Jun;98 Suppl 1(Suppl 1):i22-27. doi: 10.1136/bjophthalmol-2013-304798.

  PMID: 24836866 RESULT

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

The drawbacks of this study included the small sample size and only 12 months of follow up.

Results Point of Contact

• Title: Dr. Rishi Singh
• Organization: Cleveland Clinic Foundation

singhr@ccf.org

330-888-4000

Study Officials

• Rishi P Singh, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)