2-Year PrONTO Study Required Fewer Intravitreal Injections Than Phase 3 Trials

• Share
• E-mail
• Print

In the PrONTO (Prospective Optical Coherence Tomography [OCT] Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab) study, visual acuity outcomes were comparable with the outcomes from phase 3 clinical studies, but fewer intravitreal injections were required, according to a study in the Archives of Ophthalmology.

In the 2-year, open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 µm as measured by OCT received three consecutive monthly intravitreal injections of 0.5 mg ranibizumab (Lucentis; Genentech, Inc.)

During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled, such as an increase in OCT-CRT of at least 100 µm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT.

Forty patients were enrolled, and 37 completed the 2-year study. At month 24, the mean visual acuity improved by 11.1 letters (P<.001) and the OCT-CRT decreased by 212 µm (P<.001). Visual acuity improved by 15 letters or more in 43% of patients. These visual acuity and OCT outcomes were achieved with an average of 9.9 injections over 24 months.

Click here for more industry news and clinical trial updates.

Comment on this Article:

You must be logged in to leave a comment.

TOP 5 ARTICLES FROM 2009

• Photoreceptor Matrix Imaging in the Clinic

  Variable-field SLO and ultrahigh-speed OCT allow close-up views of retinal structures.

  By Richard B. Rosen, MD

• A Road Map for Retinal Surgical Coding in 2009

  Tips to help minimize coding mistakes and ensure proper reimbursement for surgical retina procedures performed in your practice.

  By Riva Lee Asbell

• CNTF Implant Slowed Vision Loss, Increased Retinal Thickness in Phase 2 Dry AMD
• 27-gauge Vitrectomy

  The use of these smaller instruments in vitrectomy surgery is both possible and optimal for completely self-sealing wounds.

  By Yusuke Oshima, MD, PhD

• Complications of Scleral Buckling

  By Steven Harsum, MBBS, BSc, PhD, MRCOphth; and Paul Sullivan, MD, FRCS, FRCOphth