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Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results

This study is currently recruiting participants.
Verified December 2012 by Retina Research Institute, LLC
Sponsor:
Information provided by (Responsible Party):
Gaurav K. Shah, M.D., Retina Research Institute, LLC
ClinicalTrials.gov Identifier:
NCT01657669
First received: August 2, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).


Condition Intervention Phase
Age Related Macular Degeneration
 Drug: Intravitreal Aflibercept injection
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results

Resource links provided by NLM:

Drug Information available for: Aflibercept
U.S. FDA Resources

Further study details as provided by Retina Research Institute, LLC:

Primary Outcome Measures:
  • Resolution time of intraretinal cysts and sub retinal fluid on OCT [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change in OCT central foveal thickness [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The percentage of subjects with no fluid on OCT [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The percentage of subjects who lose less than 15 letters of visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The percentage of subjects who gain greater than or equal to 15 letters of visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean change in visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean change in macular volume [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quantitative change in area (microns) from baseline in choroidal neovascular lesion characteristics/size as measured by ICG/FA/Fundus photos [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean number of injections of 2.0 mg intravitreal aflibercept injection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravitreal Aflibercept injection
Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).
 Drug: Intravitreal Aflibercept injection
Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.

Detailed Description:

Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the study.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Age 50 years and above.

Choroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300um.

Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart -

Exclusion Criteria:

Pregnancy (positive urine 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 a study or an investigational drug or device within the past 30 days prior to enrolling in the study.

Presence of significant subfoveal fibrosis or atrophy.

Previously treated subjects:

Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year.

Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.

Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months 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 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

Current vitreous hemorrhage in the study eye

History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.

Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.

Uncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 30 mmHg despite treatment with anti-glaucoma medication)

History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.

History of allergy to fluorescein, ICG or iodine, not amenable to treatment

History of retinal pigment epithelial tear or rip.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657669

Contacts
Contact: Rhonda Weeks, CCRC 314-367-1278 ext 2240 rweeks@rc-stl.com
Contact: Ginny Nobel, COT 314-367-1278 ext 2305 vnobel@rc-stl.com

Locations
United States, Missouri
The Retina Institute Recruiting
St. Louis, Missouri, United States, 63141
Contact: Rhonda F. Weeks, CCRC     314-367-1278 ext 2511     rweeks@rc-stl.com    
Contact: Ginny Nobel, COT     314-367-1278 ext 2511     vnobel@rc-stl.com    
Principal Investigator: Gaurav K. Shah, M.D.            
Sub-Investigator: Kevin J. Blinder, M.D.            
Sponsors and Collaborators
Retina Research Institute, LLC
Investigators
Principal Investigator: Gaurav K. Shah, MD The Retina Institute
  More Information

No publications provided

Responsible Party: Gaurav K. Shah, M.D., Principal Investigator, Retina Research Institute, LLC
ClinicalTrials.gov Identifier: NCT01657669     History of Changes
Other Study ID Numbers: GS-01-12
Study First Received: August 2, 2012
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Research Institute, LLC:
Choroidal neovascularization due to AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013