Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD

NCT ID: NCT00403442

Last Updated: 2008-07-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30

Brief Summary

The purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total lesion area).

To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence: 300 mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600 mW/cm2) in patients whose neovascular CNV lesions containing >50% blood.

Detailed Description

This is a phase one study in patients with all CNV lesion subtypes who are naïve to previous treatment. Lesions must have blood as a primary component (i.e., contain more than 50% blood). Patients will receive one of two combination treatments:

• Verteporfin PDT reduced fluence (300 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection
• Verteporfin PDT standard fluence (600 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection A total of 10 patients will be enrolled, 5 per treatment arm.

Conditions

Macular Degeneration

Keywords

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Verteporfin Therapy/ Drug: Bevacizumab

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients are men or women of age 50 or older.
• Patients diagnosed with subfoveal CNV due to AMD with lesion size ≤6 DA.
• Patients have not received previous treatment for subfoveal CNV, in the study eye.
• Patients with visual acuities at baseline between 20/40 and 20/320, as evaluated on ETDRS scale.
• Fluorescein Angiography showing any type of subfoveal CNV at baseline with >50% blood component of total lesion area.

Exclusion Criteria

• 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 with history of glaucoma requiring treatment, or are currently on antihypertensive treatment for elevated intraocular pressure.
• Women of childbearing potential must not be pregnant of lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control.
• Patients who have had treatment for CNV in the study eye with photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or other local treatment (e.g. submacular surgery, intravitreal triamcinolone, intra-ocular antiangiogenic agents). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
• Subject's currently who have been involved in any experimental procedure within the last 12 weeks.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

QLT Inc.

INDUSTRY

Sponsor Role: collaborator

Vitreous -Retina- Macula Consultants of New York

OTHER

Sponsor Role: lead

Principal Investigators

Jason S Slakter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vitreous Retina Macula Consultants of New York, P.C.

Locations

Vitreous Retina Macula Consultants of New York, P.C.

New York, New York, United States

Countries

United States

Other Identifiers

2303

Identifier Type: -

Identifier Source: org_study_id