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

Primary Purpose

Macular Degeneration

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Verteporfin Therapy/ Drug: Bevacizumab
Sponsored by
Vitreous -Retina- Macula Consultants of New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Number of retreatments, bevacizumab and verteporfin PDT, at either fluence rate.

Full Information

First Posted
November 22, 2006
Last Updated
July 29, 2008
Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
QLT Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00403442
Brief Title
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
Official Title
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Terminated
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
QLT Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Verteporfin Therapy/ Drug: Bevacizumab
Primary Outcome Measure Information:
Title
The primary safety variable is visual acuity and adverse events at Month 12.
Secondary Outcome Measure Information:
Title
Change in percentage of lesion hemorrhage from baseline.
Title
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
Title
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
Title
Mean change from baseline in best-corrected visual acuity score. OCT evidence of active CNV leakage which may include persistent retinal edema, subretinal
Title
fluid or pigment epithelial detachment. FA evidence of active CNV leakage which may include subretinal fluid or hemorrhage.
Title
Number of retreatments, bevacizumab and verteporfin PDT, at either fluence rate.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason S Slakter, M.D.
Organizational Affiliation
Vitreous Retina Macula Consultants of New York, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York, P.C.
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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