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This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab (PDS) in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab

2019-10-03 07:54:42 | BioPortfolio

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in participants with diabetic macular edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

Study Design

Conditions

Diabetic Macular Edema

Intervention

PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection

Location

Barnet Dulaney Perkins Eye Center
Mesa
Arizona
United States
85206

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-03T07:54:42-0400

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Medical and Biotech [MESH] Definitions

A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION.

Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.

The administration of substances into the VITREOUS BODY of the eye with a hypodermic syringe.

Endosseous dental implantation where implants are fitted with an abutment or where an implant with a transmucosal coronal portion is used immediately (within 1 week) after the initial extraction. Conventionally, the implantation is performed in two stages with more than two months in between the stages.

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