Clinical Research Services in Ophthalmology
IDDI’s unique methodologies and regulatory strategies have been validated by nearly a hundred projects for ocular drugs. We bring an experienced team of experts to maximize the value of new ophthalmologic products and devices.
IDDI’s Second Therapeutic Area of Expertise is Ophthalmology
IDDI has been involved in ophthalmology clinical trials since its inception and has successfully performed drug and device studies in all ophthalmological indications.
We have partnered with Eyetech and played a major role in the market approval of Macugen®, the first compound approved in age-related macular degeneration.
This drug was going to enter a phase II dose-ranging trial in order to determine the dose to use in phase III trial. IDDI proposed to jump ahead and test a dose-effect hypothesis in two pivotal phase III trials, using appropriate statistical methodology to adjust for multiple testing (simulations showed a step-up procedure to be slightly preferable to a closed-test procedure). Although the two trials were far larger than if a single-dose study had been conducted, this bold approach resulted in a gain of at least 1 year of clinical development ahead of its competitor. The drug has received approval by the FDA based on those trials.
IDDI Expertise in Ophthalmology Clinical Trials:
- IDDI’s team of biostatistical and clinical experts understands the key protocol design and operational considerations in ocular drugs studies.
- eCRF design is essential: we make sure only the data needed are collected. Moreover, our data managers designing the eCRFs for ophthalmology studies have a thorough understanding of the disease.
- The clinical endpoints are well known by our statisticians, who perform the analyses in the most efficient manner.
Experience (over the last 5 years):