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) - Full Text View

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:

Genetics Home Reference related topics: age-related macular degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

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


Enrollment:	9
Study Start Date:	May 2010
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (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 (Adult, Senior)
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, Inc.

Investigators


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

More Information


Responsible Party:	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 30, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016

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) (LAST)