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)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Age Related Macular Degeneration	Drug: Ranibizumab	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
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.
Study Start Date :	May 2010
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Mean Change in Visual Acuity (VA) From Baseline at Month 6 [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :

1. Mean Change in Visual Acuity (VA) From Baseline at Month 12 [ Time Frame: one year ]
   • 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

Eligibility Criteria

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

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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, Inc.

Investigators

Principal Investigator:	K.Bailey Freund, MD	Vitreous -Retina- Macula Consultants of New York

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:	NCT01115556 History of Changes
Other Study ID Numbers:	FVF4836S
First Posted:	May 4, 2010
Results First Posted:	October 6, 2017
Last Update Posted:	October 6, 2017
Last Verified:	August 2017

Additional relevant MeSH terms:

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Ranibizumab; Bevacizumab; Immunologic Factors	Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antineoplastic Agents