About the Study

In people with diabetes, high blood sugar levels can damage blood vessels in the retina (back of the eye). This condition, called diabetic retinopathy (DR), often worsens over time and can lead to serious problems with vision. Current treatment options include laser, microsurgery (called vitrectomy), and medications injected into the eye. Normally, these treatments are only used if there are already serious vision problems.

We are looking for approximately 135 people with an early stage of DR (called non-proliferative diabetic retinopathy or NPDR) to join our study. If untreated, NPDR can worsen and lead to vision loss. We want to learn if an investigational drug is safe and how it affects disease severity and vision.

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You may be able to take part in this study if you:

  • Are age 18 years or older
  • Have non-proliferative diabetic retinopathy for which you have not previously received treatment
  • Have diabetes mellitus type 1 or type 2 for which you take an oral or injectable medication
  • Have a blood glucose level (HbA1c) ≤10%
  • Have health checks and tests and answer questions to confirm you can be in the study.

What to expect if you join

The CANBERRA study will last about one year and requires 8 to 10 site visits.

If you agree to participate and screening visit tests show that you are eligible, you will be assigned by chance to one of 3 study groups. Participants in each group will take one of the following orally once daily for 36 weeks (approximately 9 months).

  • A low dose of the investigational drug
  • A high dose of the investigational drug
  • A placebo (no active drug)

The probability of being assigned to each study group is 33%.

The doses that will be tested in the study were found to be safe and well-tolerated in earlier clinical trials.

At the site visits, you will have health checks and tests including:

  • Questions about your health, medications and how you are feeling
  • Physical exam
  • Measurement of vital signs
  • Electrocardiogram (ECG) which records the electrical activity of your heart
  • Blood and urine samples
  • Vision tests
  • Eye exams and imaging

You will receive the study drug and all study-related care at no cost. You will be paid for study visits and travel costs will be reimbursed.

Interested in joining the CANBERRA Study?

Contact us to learn more about the study and find out next steps for participating.

Give us a call (888) 662-6728

Or send us an email:
global-roche-genentech-trials@gene.com

Study ID #BP41321