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Jeffrey S Heier

Publications and source records attributed to Jeffrey S Heier.

12 recordsLinked to original sources
PubMed2006

Ranibizumab for neovascular age-related macular degeneration.

BACKGROUND: Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. METHODS: In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. RESULTS: We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. CONCLUSIONS: Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].).

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PubMed2006

Ranibizumab versus verteporfin for neovascular age-related macular degeneration.

BACKGROUND: We compared ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration. METHODS: During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. RESULTS: Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P<0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P<0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P<0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%). CONCLUSIONS: Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594 [ClinicalTrials.gov].).

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PubMed2006

Implantable miniature telescope for the treatment of visual acuity loss resulting from end-stage age-related macular degeneration: 1-year results.

PURPOSE: To evaluate the safety and efficacy of an implantable visual prosthetic device (IMT; VisionCare Ophthalmic Technologies, Saratoga, CA) in patients with bilateral, end-stage age-related macular degeneration (AMD). DESIGN: Prospective, open-label, multicenter clinical trial with fellow eye controls. PARTICIPANTS: A total of 217 patients (mean age, 76 years) with AMD and moderate to profound bilateral central visual acuity loss (20/80-20/800) resulting from bilateral untreatable geographic atrophy, disciform scars, or both were enrolled. METHODS: A visual prosthetic device (implantable telescope), designed to enlarge retinal images of the central visual field, was implanted monocularly in the capsular bag after lens extraction. Fellow eyes were not implanted to provide peripheral vision and served as controls. Study patients participated in 6 visual rehabilitation visits after surgery. MAIN OUTCOME MEASURES: Best-corrected distance visual acuity (BCDVA) and best-corrected near visual acuity (BCNVA), quality-of-life scores from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) and the Activities of Daily Life scale, endothelial cell density (ECD), and incidence of complications and adverse events. RESULTS: At 1 year, 67% of implanted eyes achieved a 3-line or more improvement in BCDVA versus 13% of fellow eye controls (P<0.0001). Fifty-three percent of implanted eyes achieved a 3-line or more improvement in both BCDVA and BCNVA versus 10% of fellow eyes (P<0.0001). Mean BCDVA and BCNVA improved 3.5 lines and 3.2 lines, respectively, in implanted eyes versus 0.8 lines and 1.8 lines, respectively, in fellow eyes (P<0.0001). Change in visual acuity was not related to lesion type. Mean NEI VFQ-25 scores improved by more than 7 points from baseline (P<0.01) on 7 of 8 relevant subscales. Eleven eyes did not receive the device because of an aborted procedure. Endothelial cell density was reduced by 20% at 3 months and 25% at 1 year. The decrease in ECD was correlated with postsurgical edema (P<0.0001), and there was no evidence that endothelial cell loss is accelerated by ongoing endothelial trauma after implantation. CONCLUSIONS: This implantable visual prosthesis can improve visual acuity and quality of life in patients with moderate to profound visual impairment caused by bilateral, end-stage AMD.

Activities of Daily Living↗
PubMed2006

Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study.

OBJECTIVE: To assess safety of repeated intravitreal injections of ranibizumab in treating neovascular age-related macular degeneration (AMD), and to assess changes in visual acuity (VA) and AMD lesion characteristics. DESIGN: Multicenter, controlled, open-label, clinical trial. PARTICIPANTS: Sixty-four patients with subfoveal predominantly or minimally classic AMD-related choroidal neovascularization. METHODS: In part 1, subjects were randomized to monthly intravitreal ranibizumab for 3 months (4 injections of 0.3 mg or 1 injection of 0.3 mg followed by 3 injections of 0.5 mg; n = 53) or usual care (UC; n = 11). In part 2, subjects could continue their regimen for 3 additional months or cross over to the alternative treatment. MAIN OUTCOME MEASURES: Adverse events (AEs), intraocular pressure (IOP), VA, and lesion characteristics assessed by fluorescein angiography and fundus photography. RESULTS: Of the 64 randomized subjects, 62 completed the 6-month study. Twenty of 25 subjects (80%) randomized to 0.3 mg, and 22 of 28 subjects (79%) randomized to 0.5-mg ranibizumab in part 1 continued on that treatment in part 2; 9 of 11 (82%) subjects randomized to UC in part 1 crossed over to ranibizumab treatment in part 2. The most common AEs with ranibizumab were reversible inflammation and minor injection-site hemorrhages. Serious AEs were iridocyclitis, endophthalmitis, and central retinal vein occlusion (1 subject each). Postinjection, IOP increased transiently in 22.6% of ranibizumab-treated eyes in parts 1 and 2. After 4 ranibizumab injections (day 98), mean (+/- standard deviation) VA had increased 9.4+/-13.3 and 9.1+/-17.2 letters in the 0.3- and 0.5-mg groups, respectively, but had decreased 5.1+/-9.6 letters with UC. In part 2 (day 210), VA increased from baseline 12.8+/-14.7 and 15.0+/-14.2 letters in subjects continuing on 0.3 and 0.5 mg, respectively. Visual acuity improved from baseline > or =15 letters in 26% (day 98) and 45% (day 210) of subjects initially randomized to and continuing on ranibizumab, respectively, and areas of leakage and subretinal fluid decreased. No UC subject had a > or =15-letter improvement at day 98. CONCLUSIONS: Repeated intravitreal injections of ranibizumab had a good safety profile and were associated with improved VA and decreased leakage from choroidal neovascularization in subjects with neovascular AMD.

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PubMed2006

Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study.

OBJECTIVE: To investigate the safety and efficacy of intravitreal ranibizumab treatment combined with verteporfin photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration. METHODS: In this 2-year, phase I/II, multicenter, randomized, single-masked, controlled study, patients received monthly ranibizumab (0.5 mg) (n = 106) or sham (n = 56) injections. The PDT was performed 7 days before initial ranibizumab or sham treatment and then quarterly as needed. MAIN OUTCOMES MEASURES: Proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months (primary efficacy outcome) and the incidence and severity of adverse events. RESULTS: At 12 months, 90.5% of the ranibizumab-treated patients and 67.9% of the control patients had lost fewer than 15 letters (P<.001). The most frequent ranibizumab-associated serious ocular adverse events were intraocular inflammation (11.4%) and endophthalmitis (1.9%; 4.8% if including presumed cases). On average, patients with serious inflammation had better visual acuity outcomes at 12 months than did controls. Key serious nonocular adverse events included myocardial infarctions in the PDT-alone group (3.6%) and cerebrovascular accidents in the ranibizumab-treated group (3.8%). CONCLUSION/APPLICATION TO CLINICAL PRACTICE: Ranibizumab + PDT was more efficacious than PDT alone for treating neovascular age-related macular degeneration. Although ranibizumab treatment increased the risk of serious intraocular inflammation, affected patients, on average, still experienced visual acuity benefit.

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PubMed2006

Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration.

PURPOSE: To investigate whether multiple intravitreal doses of up to 2 mg of an antigen-binding fragment known as ranibizumab, derived from a humanized anti-vascular endothelial growth factor antibody, can be tolerated and are biologically active when injected using a dose-escalating strategy in eyes of patients with neovascular age-related macular degeneration (AMD). DESIGN: Open-label, 2-center, uncontrolled, randomized clinical study of 3 different dose-escalating regimens of ranibizumab. PARTICIPANTS: Thirty-two patients with primary or recurrent subfoveal choroidal neovascularization secondary to AMD were enrolled. Baseline best-corrected visual acuity (VA) in the study eye was from 20/40 to 20/640 (Snellen equivalent). METHODS: Treatment regimens consisted of 5, 7, or 9 intravitreal injections of ranibizumab at 2- or 4-week intervals for 16 weeks, with escalating doses ranging from 0.3 to 2.0 mg. Patients were evaluated through day 140, 4 weeks after their last injection. MAIN OUTCOME MEASURES: Safety was assessed based on ocular and nonocular adverse events, changes in VA, changes in intraocular pressure (IOP), slit-lamp ocular examination, changes in lesion characteristics based on fluorescein angiography and color fundus photography, and the presence of anti-ranibizumab antibodies. RESULTS: Twenty-nine patients received an injection at baseline, and 27 patients completed the study through day 140. Results were similar across the 3 treatment groups. All patients experienced ocular adverse events, most of which were mild. The most common ocular adverse events were iridocyclitis (83%) and injection-site reactions (72%). Inflammation did not increase with repeated injections, despite the increasing ranibizumab doses. Transient mild IOP elevations were common after ranibizumab injection. No serum anti-ranibizumab antibodies were detected. Overall, median and mean VAs in the study eyes improved by day 140 in all 3 groups. Only 3 of the 27 patients lost significant vision. There was no significant lesion growth, and a decrease in area of leakage from choroidal neovascularization was detected through day 140. CONCLUSIONS: Multiple intravitreal injections of ranibizumab at escalating doses ranging from 0.3 to 2.0 mg were well tolerated and biologically active in eyes with neovascular AMD through 20 weeks. Mild transient ocular inflammation was the most common postinjection adverse event.

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PubMed2006

A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema.

OBJECTIVE: To evaluate the biologic activity of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema (DME) and to report any associated adverse events. DESIGN: Single-center, open-label, dose-escalating pilot study. PARTICIPANTS: A total of 10 eyes of 10 patients (mean age, 69.3 years [range, 59-81]) with DME involving the center of the macula and best-corrected visual acuity (BCVA) in the study eye between 20/63 and 20/400. INTERVENTION: Three intravitreal injections of ranibizumab (0.3 mg or 0.5 mg each injection) administered on day 0, month 1, and month 2, and observation until month 24. MAIN OUTCOME MEASURES: Primary end points were the frequency and severity of ocular and systemic adverse events. Secondary end points were BCVA and measurement of retinal thickness by optical coherence tomography. RESULTS: Of the 10 patients enrolled, 5 received 0.3-mg and 5 received 0.5-mg ranibizumab. Intravitreal injections of ranibizumab were well tolerated. No systemic adverse events were reported. Five occurrences of mild to moderate ocular inflammation were reported. At month 3, 4 of 10 patients gained > or =15 letters, 5 of 10 gained > or =10 letters, and 8 of 10 gained > or =1 letters. At month 3, the mean decrease in retinal thickness of the center point of the central subfield was 45.3+/-196.3 microm for the low-dose group and 197.8+/-85.9 microm for the high-dose group. CONCLUSIONS: Ranibizumab appears to be a well-tolerated therapy for patients with DME. This pilot study demonstrates that ranibizumab therapy has the potential to maintain or improve BCVA and reduce retinal thickness in patients with center-involved clinically significant DME.

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PubMed2005

Multiple laser treatments for macular edema attributable to branch retinal vein occlusion.

PURPOSE: To report the visual outcome of multiple laser treatments for macular edema attributable to branch retinal vein occlusions (BRVO) and to determine if any prognostic factors exist for improvement. DESIGN: Retrospective chart review. METHODS: A private practice with four vitreoretinal surgeons performed laser treatments on 88 eyes of 88 patients with macular edema secondary to BRVO from 1984 to 2003. Mean preoperative and postoperative visual acuities were collected after each laser treatment. Final visual acuities were also documented. RESULTS: All 88 patients received at least one laser treatment, and 46 patients of the initial 88 underwent multiple treatments. Overall, forty-one (46.6%) of the total 88 patients improved by 2 or more lines, whereas 33 patients (37.5%) were within 1 line of the preoperative vision, and 14 patients (15.9%) worsened by 2 or more lines. The mean final visual improvement was 0.92 lines for all 88 patients. The group of patients that responded favorably to the first laser treatment (n = 37) showed an overall improvement of 3.5 lines. However, patients who responded poorly to the first laser treatment resulted in an overall worsening of vision by 0.96 lines. CONCLUSIONS: Our study found that multiple laser treatments can improve visual acuity and resolve macular edema and that each additional laser treatment gives a patient a modest chance of visual improvement. A positive or stable visual response to first laser treatment portends a favorable prognosis with subsequent laser treatments.

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PubMed2005

Preferential Hyperacuity Perimeter (PreView PHP) for detecting choroidal neovascularization study.

PURPOSE: To assess the ability of the Preferential Hyperacuity Perimeter (PreView PHP; Carl Zeiss Meditec, Dublin, CA) to detect recent-onset choroidal neovascularization (CNV) resulting from age-related macular degeneration (AMD) and to differentiate it from an intermediate stage of AMD. DESIGN: Prospective, comparative, concurrent, nonrandomized, multicenter study. PARTICIPANTS: Eligible participants' study eyes had a corrected visual acuity of 20/160 or better and either untreated CNV from AMD diagnosed within the last 60 days or an intermediate stage of AMD. METHODS: After obtaining consent, visual acuity with habitual correction, masked PHP testing, stereoscopic color fundus photography, and fluorescein angiography were performed. Photographs and angiograms were evaluated by graders masked to diagnosis and PHP results. The reading center's diagnosis determined if the patient was categorized as having intermediate AMD or neovascular AMD. MAIN OUTCOME MEASURES: A successful study outcome was defined a priori as a sensitivity of at least 80% and a specificity of at least 80%. RESULTS: Of 185 patients who gave consent to be enrolled, 11 (6%) had PHP results judged to be unreliable. An additional 52 were not included because they did not meet all eligibility criteria. Of the remaining 122 patients, 57 had an intermediate stage of AMD and 65 had neovascular AMD. The sensitivity to detect newly diagnosed CNV using PHP testing was 82% (95% confidence interval [CI], 70%-90%). The specificity to differentiate newly diagnosed CNV from the intermediate stage of AMD using PHP testing was 88% (95% CI, 76%-95%). CONCLUSIONS: Preferential Hyperacuity Perimeter testing can detect recent-onset CNV resulting from AMD and can differentiate it from an intermediate stage of AMD with high sensitivity and specificity. These data suggest that monitoring with PHP should detect most cases of CNV of recent onset with few false-positive results at a stage when treatment usually would be beneficial. Thus, this monitoring should be considered in the management of the intermediate stage of AMD.

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PubMed2005

Visual prosthetic device for bilateral end-stage macular degeneration.

Age-related macular degeneration is the leading cause of blindness in the USA. For the 1.8 million patients in the most advanced stages, there are currently no available treatments to improve vision. A visual prosthetic device that provides one eye with an enlarged retinal image of the central visual field has been developed with the goal of improving central vision in patients with bilateral end-stage macular degeneration. The other eye is left unimplanted to provide peripheral vision. This device is designed for implantation in the posterior chamber of the eye during an outpatient surgical procedure. In US Food and Drug Administration clinical trials, 72% of patients experienced an improvement in their level of visual impairment (profound or severe, to severe or moderate). This was accompanied by a clinically significant improvement in quality of life.

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PubMedDate not supplied

Preoperative visual acuity as a prognostic indicator for laser treatment of macular edema due to branch retinal vein occlusion.

BACKGROUND AND OBJECTIVE: To determine the visual outcome of laser treatments for macular edema due to branch retinal vein occlusion (BRVO) in patients with a preoperative visual acuity (VA) of 20/200 or worse compared to patients with a preoperative VA of better than 20/200. PATIENTS AND METHODS: Records of 88 patients with macular edema secondary to BRVO undergoing laser treatment from 1984 to 2003 were reviewed. Mean VA was measured before and after each treatment and after the final treatment. RESULTS: All patients received between one and five laser treatments. Preoperative VA was better than 20/200 in 56 patients (group 1) and 20/200 or worse in 32 patients (group 2). Patients in group 1 had a mean improvement of 0.48 lines and 57% had a final VA of 20/40 or better. Patients in group 2 had a mean improvement of 1.69 lines and 20% had a final VA of 20/40 or better. CONCLUSIONS: Patients with poor VA (20/200 or worse) secondary to macular edema due to BRVO responded positively to laser treatment. The level of preoperative VA can be a useful predictor of visual outcome. These patients should consider laser treatment before alternative, more aggressive approaches.

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