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A Pilot Study to Evaluate the Role of High-dose Ranibizumab (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) (LAST)

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab
Sponsored by
Vitreous -Retina- Macula Consultants of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vitreous Retina Macula Consultants of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lucentis 2.0 mg

LUCENTIS 0.5 mg

Arm Description

Lucentis 2.0 mg

Outcomes

Primary Outcome Measures

Mean Change in Visual Acuity (VA) From Baseline at Month 6

Secondary Outcome Measures

Mean Change in Visual Acuity (VA) From Baseline at Month 12
Mean change in Visual Acuity (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

Full Information

First Posted
April 30, 2010
Last Updated
May 1, 2018
Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01115556
Brief Title
A Pilot Study to Evaluate the Role of High-dose Ranibizumab (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)
Acronym
LAST
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis 2.0 mg
Arm Type
Experimental
Arm Description
Lucentis 2.0 mg
Arm Title
LUCENTIS 0.5 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
2.0 mg
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
0.5 mg
Primary Outcome Measure Information:
Title
Mean Change in Visual Acuity (VA) From Baseline at Month 6
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Mean Change in Visual Acuity (VA) From Baseline at Month 12
Description
Mean change in Visual Acuity (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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K.Bailey Freund, MD
Organizational Affiliation
Vitreous -Retina- Macula Consultants of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study to Evaluate the Role of High-dose Ranibizumab (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)

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