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

NCT00403442 | Terminated Phase 1

• 1 other identifier: 2303
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• The primary safety variable is visual acuity and adverse events at Month 12.

Secondary Outcomes (6)

• Change in percentage of lesion hemorrhage from baseline.

• The proportion of patients who lose fewer than 15 letters Less than 3 lines of best corrected visual acuity in the study eye from baseline

• The proportion of patients who gain 15 letters or more greater or equal to 3 lines of best-corrected visual acuity in the study eye from baseline

• Mean change from baseline in best-corrected visual acuity score. OCT evidence of active CNV leakage which may include persistent retinal edema, subretinal

• fluid or pigment epithelial detachment. FA evidence of active CNV leakage which may include subretinal fluid or hemorrhage.

Interventions

Verteporfin Therapy/ Drug: Bevacizumab DEVICE

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitreous -Retina- Macula Consultants of New York: lead
• QLT Inc.: collaborator

Study Sites (1)

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

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jason S Slakter, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 23, 2006
• Study Start: September 1, 2006
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

US (1)