Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD

NCT01256580 | Withdrawn

• 1 other identifier: 09-10-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choroidal Neovascularization; Myopia; Punctate Inner Choroidopathy (PIC); Multifocal Choroiditis; Ocular Histoplasmosis Syndrome; Central Serous Chorioretinopathy (CSC); Angioid Streaks; Trauma, or Hereditary Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Mean number of treatments per group

  12 months

Secondary Outcomes (1)

• Mean change in visual acuity from baseline

  12 months

Study Arms (2)

Monotherapy

ACTIVE COMPARATOR

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.

Drug: Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy

Interventions

Bevacizumab (Avastin; Genentech, Inc.) DRUG

1.25 mg bevacizumab (Avastin; Genentech, Inc.) by intravitreal injection

Monotherapy

Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy DRUG

Intravitreal injection of 1.25 mg bevacizumab (Avastin; Genentech, Inc.) combined with reduced-fluence verteporfin PDT (Visudyne®; Novartis) and 200ug of intravitreal dexamethasone

Combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age \> 18 years
• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Related Publications (1)

• 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.

  PMID: 40522203 DERIVED

MeSH Terms

Conditions

Choroidal Neovascularization; Myopia; White Dot Syndromes; Multifocal Choroiditis; Central Serous Chorioretinopathy; Angioid Streaks; Wounds and Injuries; Eye Diseases, Hereditary

Interventions

Bevacizumab; Dexamethasone

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ivana K Kim, MD

  Massachussetts Eye& Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: December 8, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01