Sight is the one sense that people fear losing due to the effect that this will have on their daily lives. The last decade has seen great advances in the understanding and treatment of disorders of the eye.

The eye is possibly one of the most specialized parts of the body. And we are a specialized CRO with a unique understanding of the field of ophthalmology. Established ophthalmic imaging techniques and specialized clinical assessments have made the eye an ideal model for complex novel clinical concepts, such as specific receptor targets, biodegradable implant technology, RNA interference and stem cell technologies. But these rapidly progressing medical advances give ophthalmic research its own unique set of challenges. We are ideally placed to help you meet them.


Our dedicated Ophthalmology group and clinical operations team have years of experience working on ophthalmology clinical trials. With our extensive ophthalmology clinical experience across the broad spectrum of indications and our regulatory experience across all geographic areas, you can be confident we’ll have given your product the best chance of seeing success.

Our ophthalmology clinical experience includes:

  • Age-related macular degeneration and polypoidal choroidal vasculophathy (PCV)
  • Diabetic eye disease (diabetic retinopathy and diabetic macular edema)
  • Dry eye / ocular surface disease
  • Geographic atrophy (GA)
  • Ocular hypertension/glaucoma (adult and pediatric)
  • Ocular infection and inflammation
  • Treatment of macular edema associated with both branch retinal vein and central retinal vein occlusion

We have worked with the key fundus photography reading centres and understand the nuances of ensuring investigation sites are certified to conduct 3 and 7 field color fundus photography, fluorescein angiography (FA), optical coherence tomography (OCT) fundus autofluorescence, indocyanine green angiography (ICG) and microperimetry prior to study start.

We are also experienced in ensuring primary endpoints such as ETDRS BCVA and measurement of intra-ocular pressure (IOP) readings and visual fields are conducted correctly.

Our work in practice

Background

An ophthalmic pharmaceutical company required a partner to lead a full-service, global program consisting of five studies: two retinal vein occlusion (RVO) studies, two diabetic macular edema (DME) studies and a uveitis study.

Solution

The program involved 1,739 participants at 272 sites across North America, Europe and Asia/Pacific. We provided EMMES-certified CRAs and expertise in OCT, fundus photography/angiography, BCVA, tonometry, slit lamp biomicroscopy, cup/disc ratio, indirect ophthalmoscopy, and NEI-VFQ25.

Result

FDA site audits had no major findings, and the program was completed in 2009. The core compound received multiple claim approval by the major regulatory bodies. This customer continues to partner with us for the development of its growing ophthalmology pipeline of compounds and indications.

We are a market-leading CRO with a dedicated ophthalmology team ready to help your product succeed. 

 

This is an estimate of INC Research studies from the last five years that are completed or scheduled to complete for this therapy area.