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Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01617148
First received: June 8, 2012
Last updated: January 27, 2014
Last verified: September 2012
  Purpose

This study will examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections. Patients will be followed for 12 months.


Condition
Exudative Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single Arm, Investigator Initiated Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Injection in Subjects With Exudative AMD Previously Treated With Ranibizumab or Bevacizumab (ASSESS Study)

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Central Foveal Thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The mean absolute change from baseline in best-corrected visual acuity score at months 6 and 12 as measured by ETDRS protocol


Estimated Enrollment: 25
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this study is to examine the use of Aflibercept in patients who have been previously treated with Ranibizumab or Bevacizumab for exudative macular degeneration. Specifically, we will examine its effect on macular degeneration, measured by SDOCT (Spectral Domain Optical Coherence Tomography) and ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity. This will be a prospective study with patients to receive an intravitreal injection of Aflibercept at the time of treatment.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects will be recruited through clinics at the Cole Eye Institute, Cleveland, OH.

Criteria

Inclusion Criteria

A subject must meet the following criteria to be eligible for inclusion in the study:

  1. Signed Informed Consent.
  2. Men and women ≥ 50 years of age.
  3. Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by historical OCTs and angiograms in the study eye.
  4. CNV must be at least 50% of total lesion size by either previous or current angiogram.
  5. ETDRS best-corrected visual acuity of: 20/25 to 20/320 (letter score of 73 to 25) in the study eye.
  6. Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
  7. At least one injection of Ranibizumab or Bevacizumab within 3 months of enrollment for active exudative AMD.
  8. Active need for anti-VEGF therapy at study entry based on the following criteria:

    1. Presence of fluid by either OCT or clinical examination (further defined as intraretinal, cystoid, subretinal, worsening pigment epithelial detachment)
    2. Presence of new hemorrhage on clinical examination
  9. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from the study:

  1. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
  2. 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.
  3. Presence of retinal pigment epithelial tears or rips involving the macula in the study
  4. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
  5. 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.
  6. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
  7. Prior vitrectomy in the study eye.
  8. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  9. Any history of macular hole of stage 2 and above in the study eye.
  10. 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.
  11. Prior trabeculectomy or other filtration surgery in the study eye.
  12. Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
  13. Active intraocular inflammation in either eye.
  14. Active ocular or periocular infection in either eye.
  15. Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
  16. Any history of uveitis in either eye.
  17. Active scleritis or episcleritis in either eye.
  18. Presence or history of scleromalacia in either eye.
  19. Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye.
  20. Previous therapeutic radiation in the region of the study eye.
  21. History of corneal transplant or corneal dystrophy in the study eye.
  22. Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
  23. Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 52 week study period.
  24. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  25. Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
  26. Any systemic with an investigational agent in the past 3 months prior to Day 1.
  27. The use of long acting intraocular steroids or photodynamic therapy in the 6 months prior to day 1.
  28. Any history of allergy to povidone iodine.
  29. Pregnant or breast-feeding women
  30. Women of childbearing potential* who are unwilling to practice adequate contraception during the study (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]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

    • *Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617148

Locations
United States, Ohio
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Rishi P Singh, MD The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01617148     History of Changes
Other Study ID Numbers: VGFTe-AMD-1211
Study First Received: June 8, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Exudative Macular Degeneration
Aflibercept

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014