Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD

NCT00426998 | Completed Phase 2

• 1 other identifier: ComB-V001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).

Conditions

Choroidal Neovascularization; Macular Degeneration

Keywords

Choroidal neovascularization due to age-related macular degeneration

Outcome Measures

Primary Outcomes (6)

• percentage of patients losing 3 or more lines of visual acuity

• percentage of patients gaining 3 or more lines of visual acuity

• mean change from baseline in visual acuity

• OCT evidence of active CNV leakage

• fluorescein angiographic evidence of active CNV leakage

• number of retreatments

Interventions

Verteporfin DRUG

Bevacizumab DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are men or women of age 55 or older
• Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
• patients have not received previous treatment for subfoveal CNV due to AMD.
• Patients have a visual acuity between 20/40 and 20/320-

You may not qualify if:

• Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
• Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
• Patients who use medications that may induce photosensitivity.
• Patients who have undergone YAG capsulotomy within the last month.
• Subjects currently involved in any experimental procedure within the last 12 weeks.
• Female patients who are pregnant, fecund or breast-feeding.

Sponsors & Collaborators

• Retinal Consultants Medical Group: lead

Study Sites (1)

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95819, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Verteporfin; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joel A Pearlman, M.D., Ph. D.

  Retinal Consultants Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 26, 2007
• Study Start: April 1, 2006
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

US (1)