Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy

September 25, 2007 updated by: Singapore National Eye Centre

Off-Label Use of AVASTIN (BEVACIZUMAB)Intravitreal Injection For the Treatment of Serosanguinous Maculopathy

To assess the use of Avastin for the management of serosanguinous maculopathy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

METHODOLOGY

Patients will be recruited from the vitreoretinal clinics at SNEC. After initial assessment, clinically and angiographically, the patient will be counselled with regards to diagnosis, prognosis and management options, including the option of intravitreal Avastin.

Inclusion criteria:

  1. All subfoveal/juxtafoveal CNV and PCV (polypoidal choroidal vasculopathy) who are not eligible for other treatment options (compassionate use)
  2. CNV and PCV lesions which have failed PDT, conventional argon laser photocoagulation (salvage use)
  3. CNV and PCV lesions treatable with PDT, but cannot afford or refused

Exclusion criteria:

  1. Patients with uncontrolled hypertension (systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
  2. History of thrombolic events such as myocardial infarction or cerebral vascular accident
  3. Renal abnormalities as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis
  4. Recent (as defined as the past 28 days) or planned (as defined as the next 3 months) surgery.
  5. Coagulation abnormalities, including anti-coagulant medication other than aspirin
  6. Patients with peptic ulcer disease
  7. Pregnant or lactating females

If the patient is agreeable to the intravitreal treatment protocol, he/she will be assessed systemically for fitness for the therapy. The serosanguinous maculopathy will be subtyped by angiographic findings to predominantly classic (>50% classic component) lesions, minimally classic (<50% classic component) lesions, occult lesions and polypoidal choroidal vasculopathy (PCV).

If the patient is eligible for the intravitreal treatment protocol, he/she will receive 1mg of Avastin intravitreally. This will be performed under aseptic technique. (See attached 'Intravitreal Injection Protocol'). The injections will be repeated every 8-10 weeks for a total of 3 treatments.

END OF TREATMENT

If the central retinal thickness is reduced by >50%, or if there is imrpovement/stablisiation of vision, or if an adverse effect (such as elevation of BP) is encountered, the treating physician can elect to withhold the Avastin treatment.

On review at the 8 and 16 weeks, the physician can elect to perform additional intravitreal Avastin treatment if any of the following should arise

  1. Loss of VA of at least 5 letters at 2 sequential visits within 2 weeks, which is associated with increased leakage from the CNV seen on angiography or OCT
  2. Increase in OCT central retinal thickness by >100um
  3. Onset of a new macular haemorrhage
  4. Development of a new classic CNV membrane
  5. Ocular outcome measurements
  6. Change from baseline in VA, i.e. gain or loss of 5 letters (1 line), 15 letters (3 lines) or 30 letters (6 lines)

Secondary outcomes

  1. Change in OCT measured central retinal thickness
  2. Correlation in change in central retinal thickness and change in VA

Once informed consent has been obtained for intravitreal Avastin therapy, the patient will be assessed for the fitness to indergo the treatment. Baseline systemic & ocular assessments will be performed. Systemic assessment will include blood pressure measurement, electrocardiogram (ECG) and blood investigations (full blood count, prothrombin time, partial thromboplastin time, bleeding time)

Once deemed fit, the patient will receive Injection 1 of intravitreal Avastin (Refer Intravitreal Injection Protocol)

The patient will then be reviewed at 1 week post-injection and then monthly for the first 2 months. Investigations at these visits will include logMAR BCVA, biomicroscopy, FFA and OCT.

At the time point of 8-10 weeks, the patient will undergo Injection 2. Followed by review at 1 week post-injection and monthly for 2 months with the same investigations as stated above.

At 16-20 weeks, the patient will receive the last treatment, Injection 3, with similar post-injection visits and investigations.

If the central retinal thickness is reduced by >50%, or if there is imrpovement/stablisiation of vision, or if an adverse effect (such as elevation of BP) is encountered, the treating physician can elect to withhold the second and/or third Avastin treatment. Hence, each patient will receive at least 1 injection of Avastin and up to a maximum of 3 injections.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All subfoveal/juxtafoveal CNV and PCV (polypoidal choroidal vasculopathy) who are not eligible for other treatment options (compassionate use)
  2. CNV and PCV lesions which have failed PDT, conventional argon laser photocoagulation (salvage use)
  3. CNV and PCV lesions treatable with PDT, but cannot afford or refused

Exclusion Criteria:

  1. Patients with uncontrolled hypertension (systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
  2. History of thrombolic events such as myocardial infarction or cerebral vascular accident
  3. Renal abnormalities (as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis).
  4. Recent (as defined as the past 28 days) or planned (as defined as the next 3 months) surgery.
  5. Coagulation abnormalities, including anti-coagulant medication other than aspirin
  6. Patients with peptic ulcer disease
  7. Pregnant or lactating females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in VA, i.e. gain or loss of 5 letters (1 line), 15 letters (3 lines) or 30 letters (6 lines)

Secondary Outcome Measures

Outcome Measure
Change in OCT measured central retinal thickness
Correlation in change in central retinal thickness and change in VA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Investigators

  • Principal Investigator: Chong-Lye Ang, FRCOphth, Singapore National Eye Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

June 23, 2006

First Submitted That Met QC Criteria

June 23, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 26, 2007

Last Update Submitted That Met QC Criteria

September 25, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R452/01/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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