We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Rhonda Weeks, Retina Research Institute, LLC.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01657669
First Posted: August 6, 2012
Last Update Posted: July 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Valley Retina Institute
Information provided by (Responsible Party):
Rhonda Weeks, Retina Research Institute, LLC
  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: None (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:


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

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

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

Enrollment: 22
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: November 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657669


Locations
United States, Missouri
The Retina Institute
St. Louis, Missouri, United States, 63128
The Retina Institute
St. Louis, Missouri, United States, 63141
United States, Texas
Valley Retina Institute
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Retina Research Institute, LLC
Valley Retina Institute
Investigators
Principal Investigator: Gaurav K. Shah, MD The Retina Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rhonda Weeks, Gaurav K. Shah, MD, Principal Investigator, Retina Research Institute, LLC
ClinicalTrials.gov Identifier: NCT01657669     History of Changes
Other Study ID Numbers: GS-01-12
First Submitted: August 2, 2012
First Posted: August 6, 2012
Last Update Posted: July 27, 2015
Last Verified: July 2015

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

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


To Top