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)

NCT01115556 | Completed Phase 1 Results

• 1 other identifier: FVF4836S
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 6 months

Secondary Outcomes (1)

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

  one year

Study Arms (2)

Lucentis 2.0 mg

EXPERIMENTAL

Lucentis 2.0 mg

Drug: Ranibizumab

LUCENTIS 0.5 mg

ACTIVE COMPARATOR

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

2.0 mg

Lucentis 2.0 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vitreous -Retina- Macula Consultants of New York: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: K. Bailey Freund, MD (or Galyna Ganieva, Research Manager)
• Organization: Vitreous Retina Macula Consultants of New York

gganieva@vrmny.com

212-861-9797

Study Officials

• K.Bailey Freund, MD

  Vitreous -Retina- Macula Consultants of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 3, 2018
• Results First Posted: October 6, 2017

Record last verified: 2018-05

Locations

US (1)