Lucentis in Advanced Macular Degeneration

NCT00896779 | Completed Phase 2 Results

• 1 other identifier: SU-04202009-2338
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections. Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails". Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy. Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean Change in Visual Acuity

  Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.

  12 months

Study Arms (2)

ranibizumab Group 1

OTHER

Group 1: 3 monthly injections of 0.5mg then prn

Drug: ranibizumab

ranibizumab Group 2

OTHER

Group 2: 6 monthly injections of 0.5 mg then prn

Drug: ranibizumab

Interventions

ranibizumab DRUG

Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

Also known as: Lucentis

ranibizumab Group 1; ranibizumab Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• 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.
• Low vision AMD patients with a VA of 20/400 or worse.
• Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT or fresh appearing subretinal hemorrhage on fundus examination.

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.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
• Participation in another simultaneous medical investigation or trial.
• Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma).

Sponsors & Collaborators

• Steven R. Sanislo: lead
• Genentech, Inc.: collaborator
• California Pacific Medical Center: collaborator
• Pacific Eye Associates: collaborator

Study Sites (2)

California Pacific Medical Center

San Francisco, California, 94107, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, 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

Limitations and Caveats

Limitations include small number of subjects analyzed and no control group that were untreated.

Results Point of Contact

• Title: Steven Sanislo, MD
• Organization: Stanford University

ssanislo@stanford.edu

650-723-6995

Study Officials

• Dr. Steven R. Sanislo

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD/PI

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 29, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-06

Locations

US (2)