BACKGROUND: To compare the efficacy of intravitreal pegaptanib (IVP) with panretinal laser photocoagulation (PRP) in the treatment of active proliferative diabetic retinopathy (PDR). METHODS: A prospective, randomised, controlled, open-label, exploratory study. Twenty subjects with active PDR were randomly assigned at a 1:1 ratio to receive treatment in one eye either with IVP (0.3 mg) every 6 weeks for 30 weeks or with PRP laser. Efficacy endpoints included regression of retinal neovascularisation (NV), changes from baseline in best-corrected visual acuity (BCVA) and foveal thickness. Safety outcomes included observed and reported adverse events. RESULTS: In 90% of randomised eyes to IVP, retinal NV showed regression by week 3. By week 12, all IVP eyes were completely regressed and maintained through week 36. In the PRP-treated group, at week 36, two eyes demonstrated complete regression, two showed partial regression, and four showed persistent active PDR. The mean change in BCVA at 36 weeks was +5.8 letters in pegaptanib-treated eyes and -6.0 letters in PRP-treated eyes. Only mild to moderate transient ocular adverse events were reported with pegaptanib. CONCLUSIONS:IVP produces short-term marked and rapid regression of diabetic retinal NV. Regression of NV was maintained throughout the study and at the final visit.
RCT Entities:
BACKGROUND: To compare the efficacy of intravitreal pegaptanib (IVP) with panretinal laser photocoagulation (PRP) in the treatment of active proliferative diabetic retinopathy (PDR). METHODS: A prospective, randomised, controlled, open-label, exploratory study. Twenty subjects with active PDR were randomly assigned at a 1:1 ratio to receive treatment in one eye either with IVP (0.3 mg) every 6 weeks for 30 weeks or with PRP laser. Efficacy endpoints included regression of retinal neovascularisation (NV), changes from baseline in best-corrected visual acuity (BCVA) and foveal thickness. Safety outcomes included observed and reported adverse events. RESULTS: In 90% of randomised eyes to IVP, retinal NV showed regression by week 3. By week 12, all IVP eyes were completely regressed and maintained through week 36. In the PRP-treated group, at week 36, two eyes demonstrated complete regression, two showed partial regression, and four showed persistent active PDR. The mean change in BCVA at 36 weeks was +5.8 letters in pegaptanib-treated eyes and -6.0 letters in PRP-treated eyes. Only mild to moderate transient ocular adverse events were reported with pegaptanib. CONCLUSIONS: IVP produces short-term marked and rapid regression of diabetic retinal NV. Regression of NV was maintained throughout the study and at the final visit.
Authors: Susan B Bressler; Haijing Qin; Michele Melia; Neil M Bressler; Roy W Beck; Clement K Chan; Sandeep Grover; David G Miller Journal: JAMA Ophthalmol Date: 2013-08 Impact factor: 7.389
Authors: Maria José Martinez-Zapata; Arturo J Martí-Carvajal; Ivan Solà; José I Pijoán; José A Buil-Calvo; Josep A Cordero; Jennifer R Evans Journal: Cochrane Database Syst Rev Date: 2014-11-24