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

This study has been terminated.
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:
NCT00403442
First received: November 22, 2006
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Device: Verteporfin Therapy/ Drug: Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD

Resource links provided by NLM:


Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

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.

Estimated Enrollment: 10
Study Start Date: September 2006
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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403442

Locations
United States, New York
Vitreous Retina Macula Consultants of New York, P.C.
New York, New York, United States, 10022
Sponsors and Collaborators
Vitreous -Retina- Macula Consultants of New York
QLT Inc.
Investigators
Principal Investigator: Jason S Slakter, M.D. Vitreous Retina Macula Consultants of New York, P.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403442     History of Changes
Other Study ID Numbers: 2303
Study First Received: November 22, 2006
Last Updated: July 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Vitreous -Retina- Macula Consultants of New York:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Bevacizumab
Verteporfin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Dermatologic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014