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Choroidal NeovascularizationCNVNCT01256580

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

A study testing Bevacizumab (Avastin; Genentech, Inc.) and Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy in people with Choroidal Neovascularization and Myopia, run by Massachusetts Eye and Ear Infirmary.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab (Avastin; Genentech, Inc.) and Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2010to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
  • Family history of glaucoma
  • Patients who have undergone intraocular surgery within last 2 months
  • Aphakia or absence of the posterior capsule in the study eye Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.

About this study

Official title: Pilot Study of Intravitreal Bevacizumab vs. Combination Therapy for Choroidal Neovascularization Secondary to Causes Other Than Age-related Macular Degeneration

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.

Being tested
Bevacizumab (Avastin; Genentech, Inc.), Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy
Medical subject headings
Choroidal Neovascularization, Myopia, White Dot Syndromes, Multifocal Choroiditis, Central Serous Chorioretinopathy, Angioid Streaks, Wounds and Injuries, Eye Diseases, Hereditary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab (Avastin; Genentech, Inc.)Drug

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

  • Bevacizumab, Dexamethasone, Verteporfin Photodynamic TherapyDrug

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

Study groups in NCT01256580
Study groupRoleWhat they receive
MonotherapyActive comparatorBevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings
Receives: Drug: Bevacizumab (Avastin; Genentech, Inc.)
Combination therapyActive comparatorIntravitreal 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.
Receives: Drug: Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean number of treatments per group

    Measured: 12 months

Secondary outcomes (1)

  1. Mean change in visual acuity from baseline

    Mean change in visual acuity from baseline

    • Proportion of subjects losing ≤8 letters (≈1.5 lines) from baseline
    • Proportion gaining ≥15 letters from baseline
    • Proportion with a Snellen equivalent of 20/200 or worse (legal blindness = 20/200 or worse in both eyes)
    • Mean change from baseline in total area of CNV and total area of leakage from CNV from baseline to month 12 by FA Mean change in central subfield macular thickness (CMT) measured by OCT from baseline to month 12 Change of in areas of hypoautofluorescence (indicating atrophy) from baseline to month 12

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2013 (estimated)
  4. Study completionSep 2013 (estimated)

Why it stopped: Lack of eligible subjects.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01256580
Sponsor's protocol ID
09-10-101
Acronym
CNV
Status last verified
Jan 2014
First submitted
29 Oct 2010
Last updated
14 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40522203

Questions about this trial

What is this clinical trial studying?

A study testing Bevacizumab (Avastin; Genentech, Inc.) and Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy in people with Choroidal Neovascularization and Myopia, run by Massachusetts Eye and Ear Infirmary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean number of treatments per group (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.

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