Advertisement

Topics

Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions

2010-07-15 17:00:00 | BioPortfolio

Summary

The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to retinal vein occlusion.

Description

The secondary objectives are to assess the bioactivity of 0.5 or 2.0 mg of ranibizumab in patients with macular edemas due to retinal vein occlusion by measuring the mean change from baseline in several parameters of visual function and retinal thickness at weeks 24 and 48. In addition, aqueous levels of cytokines and ranibizumab will be measured to assess for biomarkers of disease activity and response and to perform a pharmacodynamic analysis by correlating aqueous levels of ranibizumab with the above outcome measures. At week 24, patients will be re-randomized to receive laser photocoagulation to areas of capillary nonperfusion outside the fovea to assess the safety and tolerability of combination treatment with laser and ranibizumab.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Retinal Vein Occlusion

Intervention

Ranibizumab .5mg, Ranibizumab .5mg with laser, Ranibizumab 2.0 mg, Ranibizumab 2.o dose with laser

Location

Wilmer Eye Institute at Johns Hopkins University
Baltimore
Maryland
United States
21287

Status

Recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

Clinical Trials [939 Associated Clinical Trials listed on BioPortfolio]

A Study of Ranibizumab Administered Monthly or on an As-Needed Basis in Patients With Subfoveal Neovascular Age-Related Macular Degeneration

This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with CNV seco...

Ranibizumab for the Inhibition of Neovascularization in Pterygia

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)

The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.

Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments

This is a multicenter, randomized, open-label study. 30 patients will be followed for a period of 12 months. All consented and enrolled patients will receive 0.5mg of intravitreal ranibi...

Evaluation of Dosing Interval of Higher Doses of Ranibizumab

The purpose of this study is to test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macul...

PubMed Articles [6218 Associated PubMed Articles listed on BioPortfolio]

3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients.

The prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therap...

Photodynamic therapy in combination with ranibizumab versus ranibizumab monotherapy for wet age-related macular degeneration: A systematic review and meta-analysis.

To evaluate the efficacy and safety between photodynamic therapy (PDT) combined with intravitreal ranibizumab (IVR) and ranibizumab monotherapy in treating wet age-related macular degeneration (AMD).

Long-term results of photodynamic therapy or ranibizumab for polypoidal choroidal vasculopathy in LAPTOP study.

We previously reported that ranibizumab performed better on visual prognosis than photodynamic therapy (PDT) in a Ranibizumab (ucentis) nd hotodynamic herapy n olypoidal choroidal vasculopathy (LAPTOP...

Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 μg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I).

Visual outcomes of the FAME study (0.2 μg/day fluocinolone acetonide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method.

An analysis of ranibizumab treatment and visual outcomes in real-world settings: the UNCOVER study.

To describe intravitreal ranibizumab treatment frequency, clinical monitoring, and visual outcomes (including mean central retinal thickness [CRT] and visual acuity [VA] changes from baseline) in neov...

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.

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.

Treatment using irradiation with LASER light of low power intensity so that the effects are not due to heat, as in LASER THERAPY. These non-thermal effects are thought to be mediated by a photochemical reaction that alters CELL MEMBRANE PERMEABILITY, leading to increased mRNA synthesis and CELL PROLIFERATION. Low-level laser therapy has been used for a wide variety of conditions, but most frequently for wound healing and pain control.

More From BioPortfolio on "Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial