A Pilot Study to evaLuate the Role of High-dose rAnbizumab (2.0mg) in the Management of AMD in Patients With perSistent/recurrenT Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Vitreous -Retina- Macula Consultants of New York.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:
NCT01115556
First received: April 30, 2010
Last updated: December 14, 2011
Last verified: May 2010
  Purpose

This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment.

The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: Ranibizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: This is a Single-masked Study to Compare Intravitreally Administered 0.5 mg Ranibizumab to 2.0 mg Ranibizumab in Subjects Who Manifest Persistent or Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy.

Resource links provided by NLM:


Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

Primary Outcome Measures:
  • Mean change in VA from Baseline at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in VA from Baseline at Month 12 [ Time Frame: one year ] [ Designated as safety issue: No ]
    • Mean change in VA from Baseline at Month 12
    • Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12
    • Mean change in leakage as determined by FA at Months 6 and 12
    • Mean number of ranibizumab injections at Months 6 and 12
    • Mean time to first re-treatment following the initial 3 monthly loading doses
    • Mean duration of fluid-free interval
    • Safety and tolerability of 2.0mg using the incidence and severity of adverse events


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucentis 2.0 mg
Lucentis 2.0 mg
Drug: Ranibizumab
2.0 mg
Active Comparator: LUCENTIS 0.5 mg Drug: Ranibizumab
0.5 mg

  Eligibility

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

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 50 years
  • Subfoveal neovascularization secondary to AMD
  • Best corrected visual acuity in the study eye between 20/30 to 20/400 using an ETDRS chart
  • Documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy
  • Presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

  • 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 triamcinolone in the study eye within 6 months of BSL.
  • Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
  • Past treatment with PDT or thermal laser in the study eye
  • 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
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Uncontrolled glaucoma in the study eye (defined as IOP ≥ 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, not amenable to treatment
  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: NCT01115556

Locations
United States, New York
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022
Sponsors and Collaborators
Vitreous -Retina- Macula Consultants of New York
Genentech
Investigators
Principal Investigator: K.Bailey Freund, MD Vitreous -Retina- Macula Consultants of New York
  More Information

No publications provided

Responsible Party: K.Bailey Freund MD, Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier: NCT01115556     History of Changes
Other Study ID Numbers: FVF4836S
Study First Received: April 30, 2010
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014