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Treatment of inflammatory macular edema with humanized anti-CD11a antibody therapy.

ABSTRACT: To evaluate the safety and efficacy of treating macular edema, secondary to noninfectious uveitis, with a humanized anti-CD11a antibody.Six patients received weekly subcutaneous treatments for 16 weeks according to this open-label, prospective, noncomparative phase I/II trial. Best corrected visual acuity (BCVA) and central macular thickness (CMT) were compared to baseline. Adverse events were recorded and assessed. Blood was sampled to assess the levels of CD56(bright) regulatory NK cells before initiation and after termination of the study.No serious adverse events were reported by the patients. Patients' ages ranged from 22 to 82 years. Mean BCVA improvements were 6.7 ± 6.9 ETDRS letters in the worse eye and 1.7 ± 5.2 letters in the better eye. Mean CMT reductions were 128 ± 105 ?m in the worse eye and 57 ± 68 ?m in the better eye. Anti-CD11a antibody treatments resulted in an increase in the CD56(bright) regulatory NK cell population in the peripheral blood of the patients.Anti-CD11a treatment improved visual function, reduced macular thickness, and increased the level of CD56(bright) regulatory NK cells in patients with uveitic macular edema refractory to other immunosuppressive medications. Targeting CD11a may be beneficial in treating other causes of macular edema.

SUBMITTER: Faia LJ

PROVIDER: S-EPMC3176000 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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Treatment of inflammatory macular edema with humanized anti-CD11a antibody therapy.

Faia Lisa J LJ Sen H Nida HN Li Zhuqing Z Yeh Steven S Wroblewski Keith J KJ Nussenblatt Robert B RB

Investigative ophthalmology & visual science 20110901 9

<h4>Purpose</h4>To evaluate the safety and efficacy of treating macular edema, secondary to noninfectious uveitis, with a humanized anti-CD11a antibody.<h4>Methods</h4>Six patients received weekly subcutaneous treatments for 16 weeks according to this open-label, prospective, noncomparative phase I/II trial. Best corrected visual acuity (BCVA) and central macular thickness (CMT) were compared to baseline. Adverse events were recorded and assessed. Blood was sampled to assess the levels of CD56(b ...[more]

PMID: 21498606

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Project description:Diabetes mellitus is a serious health problem that affects over 350 million individuals worldwide. Diabetic retinopathy (DR), which is the most common microvascular complication of diabetes, is the leading cause of new cases of blindness in working-aged adults. Diabetic macular edema (DME) is an advanced, vision-limiting complication of DR that affects nearly 30% of patients who have had diabetes for at least 20 years and is responsible for much of the vision loss due to DR. The historic standard of care for DME has been macular laser photocoagulation, which has been shown to stabilize vision and reduce the rate of further vision loss by 50%; however, macular laser leads to significant vision recovery in only 15% of treated patients. Mechanisms contributing to the microvascular damage in DR and DME include the direct toxic effects of hyperglycemia, sustained alterations in cell signaling pathways, and chronic microvascular inflammation with leukocyte-mediated injury. Chronic retinal microvascular damage results in elevation of intraocular levels of vascular endothelial growth factor A (VEGF), a potent, diffusible, endothelial-specific mitogen that mediates many important physiologic processes, including but not limited to the development and permeability of the vasculature. The identification of VEGF as an important pathophysiologic mediator of DME suggested that anti-VEGF therapy delivered to the eye might lead to improved visual outcomes in this disease. To date, four different inhibitors of VEGF, each administered by intraocular injection, have been tested in prospective, randomized phase II or phase III clinical trials in patients with DME. The results from these trials demonstrate that treatment with anti-VEGF agents results in substantially improved visual and anatomic outcomes compared with laser photocoagulation, and avoid the ocular side effects associated with laser treatment. Thus, anti-VEGF therapy has become the preferred treatment option for the management of DME in many patients.

Project description:BackgroundDiabetic macular edema (DME) is a major cause of vision loss in diabetics that is currently mainly treated by antivascular endothelial growth factor (VEGF) agents. The effect of these agents on macular perfusion (MP) is a current concern. Optical coherence tomography angiography (OCTA) is an imaging modality that allows noninvasive high-resolution retinal microvasculature imaging. Several recent studies evaluated the effect of anti-VEGF agents on the MP of DME patients using OCTA. Our aim is to provide a systematic review of these studies.MethodsMultiple databases were searched including PubMed, Ovid Medline, EMBASE, and Google Scholar for relevant studies published between January 2016 and November 2020 which were included in this review. Studies were compared regarding their design, the number of included patients, the machine and scanning protocol used, the inclusion and exclusion criteria, the number of injections given, the type of anti-VEGF agent used, the outcome measures assessed, and the effect of injections on different MP parameters.ResultsA total of 16 studies were included. The studies assessed various OCTA parameters that define MP including the foveal avascular zone area and superficial and deep vascular density and yielded conflicting results. Seven studies showed stable or improved MP following treatment, while 7 studies showed worsening MP following treatment, and 2 studies showed inconclusive results. This could have been due to differences in study design, inclusion criteria, type of anti-VEGF agents used, treatment duration, and methods of image analysis and vascular density quantification. All identified studies were noncomparative case series, and 14 of them (87.5%) used the RTVue XR Avanti OCTA machine. Only one study compared OCTA to fluorescein angiography findings.ConclusionAnalysis of MP changes following VEGF inhibition for DME could benefit from a unified scanning protocol and analysis approach that uses similar study designs to eliminate potential sources of bias. This may provide more definitive conclusions regarding the effect of treatment on MP.

Dataset Information

Treatment of inflammatory macular edema with humanized anti-CD11a antibody therapy.

Publications

Treatment of inflammatory macular edema with humanized anti-CD11a antibody therapy.

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