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

A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00426998
Enrollment
30
Registered
2007-01-26
Start date
2006-04-30
Completion date
Unknown
Last updated
2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Neovascularization, Macular Degeneration

Keywords

Choroidal neovascularization due to age-related macular degeneration

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).

Interventions

DRUGVerteporfin
DRUGBevacizumab

Sponsors

Retinal Consultants Medical Group
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients are men or women of age 55 or older 2. Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA 3. patients have not received previous treatment for subfoveal CNV due to AMD. 4. Patients have a visual acuity between 20/40 and 20/320-

Exclusion criteria

1. 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. 2. 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. 3. Patients who use medications that may induce photosensitivity. 4. Patients who have undergone YAG capsulotomy within the last month. 5. Subjects currently involved in any experimental procedure within the last 12 weeks. 6. Female patients who are pregnant, fecund or breast-feeding. \-

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026