Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD
CNV
Pilot Study of Intravitreal Bevacizumab vs. Combination Therapy for Choroidal Neovascularization Secondary to Causes Other Than Age-related Macular Degeneration
This date has not been verified as actual or estimated.
Primary Completion
March 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brief Summary
Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV) due to other causes. The limitation of this type of treatment is the necessity for frequent intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy in combination with photodynamic therapy can reduce the number of treatments needed with monotherapy while achieving similar visual results. There are ongoing multicenter trials evaluating combination therapy in patients with wet AMD but no similar trial for patients with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on patients with CNV not due to AMD.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
withdrawn
Actual enrollment (reported)
0 participants
Study completion date
September 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations
0 countries · 0 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
August 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 29, 2010
Actual (reported)
First Posted
December 8, 2010
Actual (reported)
Primary Completion
March 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Bevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings
Drug: Bevacizumab (Avastin; Genentech, Inc.)
Combination therapy
ACTIVE COMPARATOR
Intravitreal injection of bevacizumab 1.25 mg (Avastin; Genentech, Inc.) combined with reduced fluence PDT(Visudyne®; Novartis,) and 200 ug of intravitreal dexamethasone(4mg/ml, American regent, Inc) on Day 0 and then monthly retreatment with bevacizumab as-needed and triple therapy every 3 months as-needed.
Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
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Clinical diagnosis of choroidal neovascularization secondary to the following causes: ocular histoplasmosis, toxoplasmosis, idiopathic, angioid streaks, choroidal ruptures, intraocular inflammation (without signs of active uveitis i.e. multifocal choroiditis), central serous retinopathy and pathologic Myopia.
Only one eye will be assessed in the study. If both eyes are eligible, the investigator and patient will determine which eye is to be treated, considering such factors as disease duration, and likelihood of response to treatment.
Clear media and dilation to permit good stereo fundus photography
Evidence of active CNV present on OCT images manifest by subretinal fluid, intraretinal fluid or retinal thickening ≥ 250 µm
Best corrected VA in the study eye must be 20/40 and to 20/400 at 4 meters using ETDRS protocol.
You may not qualify if:
Pregnancy or lactation
Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; and IUD; or contraceptive hormone implant or patch.
CNV secondary to AMD
Diabetic Retinopathy
Prior enrollment in clinical studies in the study eye
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Previous participation in another simultaneous medical investigation or trial within 1 month preceding Day 0 (excluding vitamins and minerals)
Use of drug or treatment related or unrelated to their condition within 30 days prior to enrollment (Verteporfin, pegaptanib, ranibizumab, bevacizumab, triamcinilone or other AMD therapy in study eye)
Concurrent use of systemic anti-VEGF therapy
Any other ocular condition the investigator believes would pose a significant hazard to the subject if investigational treatment were initiated
History of allergy to fluorescein
Inability to obtain fundus photographs or FAs of sufficient quality to document CNV
Inability to comply with study or follow-up procedures
History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
Current treatment for active systemic infection
+4 more criteria
Contact the study team to confirm eligibility.
Metaplasia
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Refractive Errors
Uveitis, Posterior
Panuveitis
Uveitis
Choroiditis
Retinal Diseases
Genetic Diseases, Inborn
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2014
Record last verified: 2014-01
Source record
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Source: ClinicalTrials.gov.
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