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Publications (3)11.51 Total impact

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    ABSTRACT: Purpose: To compare long-term vision and anatomic effects of ranibizumab with prompt or deferred laser versus laser or triamcinolone+laser with very deferred ranibizumab in diabetic macular edema (DME). Design: Randomized clinical trial METHODS: Eight hundred and twenty eight study eyes (588 [67%] completed the 5-year visit), at 52 sites, with visual acuity 20/32 to 20/320 and DME involving the central macula were randomly assigned to intravitreous ranibizumab (0.5mg) with either 1) prompt or 2) deferred laser; 3) sham injection+prompt laser; or 4) intravitreous triamcinolone (4mg)+prompt laser. The latter two groups could initiate ranibizumab as early as 74 weeks from baseline, for persistent DME with vision impairment. The main outcome measures were visual acuity, optical coherence central subfield thickness, and number of injections through five years. Results: At five years mean (± standard deviation) change in Early Treatment Diabetic Retinopathy Study visual acuity letter scores from baseline in the ranibizumab+deferred laser (N=111), ranibizumab+prompt laser (N=124), laser/very deferred ranibizumab (N=198), and triamcinolone+laser/very deferred ranibizumab (N=125) groups were 10±13, 8±13, 5±14, and 7±14 respectively. The difference (95% confidence interval) in mean change between ranibizumab+deferred laser and laser/very deferred ranibizumab and triamcinolone+laser/very deferred ranibizumab was 4.4 (1.2 to 7.6, P=0.001) and 2.8 (-0.9 to 6.5, P=0.067) respectively at 5 years. Conclusions: Recognizing limitations of follow-up available at 5 years, eyes receiving initial ranibizumab therapy for center-involving DME, likely have better long-term vision improvements than eyes managed with laser or triamcinolone+laser followed by very deferred ranibizumab for persistent thickening and vision impairment.
    No preview · Article · Jan 2016 · American Journal of Ophthalmology
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    ABSTRACT: To evaluate 14-week effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation. Three hundred and forty-five eyes with a visual acuity of 20/320 or better, center-involved diabetic macular edema receiving focal/grid laser, and diabetic retinopathy receiving prompt panretinal photocoagulation were randomly assigned to sham (n = 123), 0.5-mg ranibizumab (n = 113) at baseline and 4 weeks, and 4-mg triamcinolone at baseline and sham at 4 weeks (n = 109). Treatment was at investigator discretion from 14 weeks to 56 weeks. Mean changes (±SD) in visual acuity letter score from baseline were significantly better in the ranibizumab (+1 ± 11; P < 0.001) and triamcinolone (+2 ± 11; P < 0.001) groups compared with those in the sham group (-4 ± 14) at the 14-week visit, mirroring retinal thickening results. These differences were not maintained when study participants were followed for 56 weeks for safety outcomes. One eye (0.9%; 95% confidence interval, 0.02%-4.7%) developed endophthalmitis after receiving ranibizumab. Cerebrovascular/cardiovascular events occurred in 4%, 7%, and 3% of the sham, ranibizumab, and triamcinolone groups, respectively. The addition of 1 intravitreal triamcinolone injection or 2 intravitreal ranibizumab injections in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation is associated with better visual acuity and decreased macular edema by 14 weeks. Whether continued long-term intravitreal treatment is beneficial cannot be determined from this study.
    Full-text · Article · Mar 2011 · Retina (Philadelphia, Pa.)
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    ABSTRACT: To report the incidence of endophthalmitis after intravitreal drug injection by means of a standardized procedure that does not require topical antibiotics, sterile gloves, or a sterile drape. Intravitreal injections of preservative-free triamcinolone acetonide or ranibizumab were administered in 2 prospective randomized clinical trials performed by the Diabetic Retinopathy Clinical Research Network. The standardized procedure for these trials requires the use of a topical combination product of povidone-iodine, a sterile lid speculum, and topical anesthetic, but does not require the use of topical antibiotics before, on the day of, or after injection. As of February 23, 2009, a total of 3226 intravitreal injections of ranibizumab and 612 injections of preservative-free triamcinolone had been administered. Topical antibiotics were given on the day of injection in 361 (9.4%) of the 3838 cases, for several days after injection in 813 cases (21.2%), on the day of injection and after injection in 1388 cases (36.2%), and neither on the day of injection nor after injection in 1276 cases (33.3%). Three cases of culture-positive endophthalmitis occurred after ranibizumab injections (0.09%), and no cases occurred after triamcinolone injections. In all 3 cases of endophthalmitis, topical antibiotics were given for several days after the injection but not before injection. The results suggest that a low rate of endophthalmitis can be achieved by means of a protocol that includes use of topical povidone-iodine, a sterile lid speculum, and topical anesthetic, but does not require topical antibiotics, sterile gloves, or a sterile drape. Trial Registration clinicaltrials.gov Identifiers: NCT00444600 and NCT00445003.
    Full-text · Article · Dec 2009 · Archives of ophthalmology