Evaluation of Dosing Interval of Higher Doses of Ranibizumab

NCT00533520 | Completed Phase 4 DMC

• 1 other identifier: FVF4155s
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Conditions

Macular Degeneration; Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection

  24 months

Secondary Outcomes (1)

• Injection interval: mean time and number of injections

  24 months

Study Arms (3)

0.5mg ranibizumab

ACTIVE COMPARATOR

Subjects will be treated with 0.5mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.

Drug: ranibizumab

1.0mg ranibizumab

ACTIVE COMPARATOR

Subjects will be treated with 1.0mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.

Drug: ranibizumab

2.0mg ranibizumab

ACTIVE COMPARATOR

Subjects will be treated with 2.0 mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.

Drug: ranibizumab

Interventions

ranibizumab DRUG

Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days

Also known as: rhuFab V2

0.5mg ranibizumab; 1.0mg ranibizumab; 2.0mg ranibizumab

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment naive macular degeneration patients with choroidal neovascularization
• \>50 years old
• Visual acuity 20/40 to 20/320

You may not qualify if:

• Pregnancy
• Previous history of thromboembolic event including myocardial infarction or stroke

Sponsors & Collaborators

• Brandon G. Busbee, MD: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Tennessee Retina, P.C.

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Brandon G Busbee, MD

  Tennessee Retina, P.C,.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 21, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

US (1)