MedPath

BRDME.

Conditions
eeftijdsgebonden macula degeneratieDiabetisch retinopathie
Registration Number
NL-OMON27161
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
246
Inclusion Criteria

1. Male or female patients > 18 years of age who have signed an informed consent;

2. Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization (WHO) guidelines) with glycosylated haemoglobin (HbA1c) less than 12.0% at screening (Visit 1). Patients should be on a dietary, exercise and/or pharmacological program for diabetes. Treatment for diabetes must have been stable for at least 2 months;

Exclusion Criteria

1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent;

2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test (human chorionic gonadotropin > 5 mIU/ml);

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome is the change in best-corrected visual acuity (BCVA) in the study eye from Baseline to Month 6 assessed with ETDRS-like VA charts at an initial distance of 4 meter.
Secondary Outcome Measures
NameTimeMethod
1. The proportion of patients with a loss of BCVA less than 15 letters from baseline at 6 months (responders);<br /><br>2. The proportion of patients with a loss or gain of BCVA less than 15 letters from baseline at 6 months (stabilizers);<br /><br>3. The proportion of patients with 15 letters loss or more of BCVA from baseline at 6 months (non-responders);<br /><br>4. The proportion of patients with 15 letters gain or more of BCVA from baseline at 6 months (gainers);<br /><br>5. The incidence of fluorescein leakage at 6 months as well as the change from baseline at 6 months as determined by the reading centre;<br /><br>6. Absolute and percent change in retinal thickness, as measured by optical coherence tomography (OCT) at 6 months as determined by the reading centre;<br /><br>7. Proportion of dropouts before the final 6 months assessments;<br /><br>8. The occurrence of (serious) adverse events during the 6 months of the study;<br /><br>9. Costs of the two treatments (see economic evaluation).
© Copyright 2025. All Rights Reserved by MedPath