Symptoms and General Pathology

All Conditions

Eye Diseases

Heart and Blood Diseases

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Syndrome

Glaucoma

Klippel-Trenaunay-Weber Syndrome

Sturge-Weber Syndrome

Infarction

Brain Stem Infarctions

Hypertension

Ocular Hypertension

Brain Infarction

Ischemia

Brain Ischemia

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Stroke

Vascular Diseases

Necrosis

Angiomatosis

Hemangioma

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Neurocutaneous Syndromes

Klippel-Trenaunay Syndrome

Parkes Weber Syndrome

Weber Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Mitomycins

Mitomycin

Glycolic acid

Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome

Ahmed valve will be implanted alone with no PLGA

Ahmed valve implantation coated with poly lactic -co-glycolic acid (PLGA) saturated with Mitomycin-C in the management of adult onset glaucoma in Sturge Weber syndrome

Ahmed Valve

Hany Mahmoud, MD

Hany Mahmoud

Sturge weber's syndrome is an oculcutaneous syndrome, ocular manifestations may include heamangioma in the eye lids, choroidal heamangioma, or glaucoma, the glaucoma may present at infancy and may be due to resistance to aqueous outflow through trabecular meshwork(1), it may develop later and this is due to episcleral venous raised pressure.(2-3) Glaucoma associated with Sturge weber syndrome is difficult to be treated medically with high risk of complications when treated with bleb -based surgeries. Suprachoroidal hemorrhage or detachment is a challenging complication which must be encountered.

The usage of Ahmed valve in the management of glaucoma associated with Sturge weber syndrome is a bleb based procedure carries the risks of over filtration or encapsulation and decreased filtration with failure to control glaucoma.

The use of Ahmed valve in the management of pediatric glaucoma associated with Sturge weber syndrome has better results as recorded by Nassiri et al. Ahmed valve implantation can have some drawbacks such as pupillary irregularity, lens opacification, or encapsulation.(4-7) Glaucoma drainage devices such as Ahmed valve, Molteno or Braeveldt valve can be used when other methods of treatment fail, they provide alternative pathway to the aqueous to be collected in a plate positioned under the conjunctiva, (8-10) Encapsulation is a major problem occurs around the end plate due to fibrous reaction and so the drainage of the aqueous is decreased , Epatein (11) attributed that to fibro vascular proliferation in the episcleral tissue .the fibrous reaction is multifactorial , it may be due to the size of the end plate, the biomaterial, design or the shape of the plate.

The use of drainage devices with advanced drug delivery system can improve the success of drainage device.

A double-layered porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid) (PLGA) was described by Ponnusamy et al. \[12\] to produce continuous release of antifibrotic agents \[mitomycin C (MMC) and/or 5-fluorouracil (5-FU)\] to the subconjunctival space. This release continue for about one month with decreasing fibrosis, the nanofiltration membrane could entrap the proteins passing out from the anterior chamber leading to minimal increase in aqueous resistance.(12-13)

All participants will be evaluated regarding the following:

Visual acuity (VA) will be measured before and after surgery. Visual field (VF) will be assessed. Optical coherence topography (OCT) Ahmed valve coated with PLGA nanoparticles saturated with Mitomycin-C 2mg/ml. Follow up will continue for one year regarding intraocular pressure IOP, VA , VF, OCT and occurrence of complications such as erosion, extrusion, infection, encapsulation and fibrosis around the stent.

Data will be collected and analyzed.

Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome

efficacy of Ahmed valve implantation coated with PLGA sturated with MMC

to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.

Sohag University

principal investigator

Pharmaceutical Solutions

Ophthalmic Solutions

Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes

ophthalmic solution in a single use dropper vial

QLS-101 ophthalmic solution, 2.0 %

Sharon Freedman, M.D.

Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Incidence of ocular treatment emergent adverse events (TEAEs)

Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101

Qlaris Bio, Inc.

Ganglion Cysts

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

Oculocerebral Syndrome With Hypopigmentation

Micronutrients

Vasodilator Agents

Lipid Regulating Agents

Hematinics

Vitamins

Niacinamide

Niacin

Nicotinic Acids

Vitamin B Complex

Folic Acid

Trace Elements

Hypolipidemic Agents

Antimetabolites

Nicotinamide

Nicotinic Acid

Vitamin B3

Folate

Vitamin B9

Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID)

Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID)

Nicotinamide(Mitovita)

Placebo

Seungsoo Rho, MD, PhD

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks

Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks

Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks

Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation

Change of visual field sensitivity number of locations in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total, pattern deviation

Hanlim Pharm. Co., Ltd.

CHA University

Low Tension Glaucoma

Optic Nerve Diseases

Frederick Mikelberg, MD

The purpose of this study is to study the occurrence rate of masses such as brain tumors in patients with newly diagnosed Normal Tension Glaucoma.

Magnetic Resonance Imaging of Patients With Normal Tension Glaucoma

Neuroradiologic Screening of Patients With Normal Tension Glaucoma

University of British Columbia

Dr. Frederick Mikelberg

Hydrophthalmos

Congenital Abnormalities

Eye Abnormalities

Glaucoma, Open-Angle

Infant, Newborn, Diseases

Glaucoma, Congenital

dosed once a day for 14 days as either first or second dosing period per randomization

dosed once a day for 14 as either first or second dosing period per randomization

QLS-101ophthalmic solution 1%

QLS-101ophthalmic solution 2%

B. Wirostko, M.D.

Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).

Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.

Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Standard safety endpoint, ocular AEs, (including elevated IOP)

Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline

Standard safety endpoint, EDI-OCT, corneal thickness

Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline

Fundus exam, abnormalities, changes from baseline

Mean change in IOP from baseline following 14 days dosing

Latanoprost

Patients with glaucomatous optic neuropathy defined as narrowing of the neuroretinal rim, notching, excavation, or RNFL defect; and repeatable standard automated perimetry abnormality defined as a glaucoma hemifield test (GHT) "outside normal limits" or pattern standard deviation (PSD) outside 95% normal limits were included.

Ocular hypertension defined as an intraocular pressure ≥ 24 mm Hg and ≤ 32 mm Hg in one eye and IOP ≥ 22 mm Hg and ≤ 32 mm Hg in the fellow eye, with normal optic disc, normal visual field defined as follows mean Deviation (MD) or Pattern Standard Deviation (PSD) of p\>5%, normal Glaucoma Hemifield Test (GHT) and reliable visual field exam

latanoprost 0.005%

David S Greenfield, MD

The purpose of this investigation is to evaluate the relationship between IOP fluctuation, RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo.

It has been hypothesized that intraocular (IOP) variability is an independent risk factor for the progression of glaucoma. IOP variability includes 24 hour IOP fluctuation during the waking period (diurnal fluctuation) and sleep period (nocturnal fluctuation) as well as longitudinal IOP variability measured in the diurnal period over the course of multiple office visits.

Latanoprost has been clinically used to lower eye pressure in glaucoma and ocular hypertension for almost 10 years. Latanoprost 0.005% has been demonstrated to provide superior ocular hypotensive efficacy compared with timolol 0.5% in pivotal phase 3 clinical trials (Alm et al. 1995; Camras 1996).

The Pattern Electroretinogram (PERG) is a non-invasive technology that objectively measures the retinal ganglion cell (RGC) function (Porciatti and Ventura 2004). A recent study has demonstrated that the RGC function can be improved following IOP reduction in glaucomatous eyes with early visual field defects (Ventura and Porciatti 2005).

The purpose of this investigation is to evaluate the relationship between IOP fluctuation, RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo.

Relationship Between Eye Pressure and Ganglion Cell Function in Eyes Receiving Latanoprost Versus Placebo

Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo

RGC function is evaluated by pattern electroretinogram optimized for glaucoma (PERGLA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome	NCT04735601	Glaucoma	Ahmed Valve	18 Years -	Sohag University
Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome	NCT04735601	Glaucoma	Ahmed Valve	18 Years -	Sohag University
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)	NCT05495269	Sturge-Weber Sy... Glaucoma Ocular Hyperten...	QLS-101 ophthal...	12 Years - 19 Years	Qlaris Bio, Inc.
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients	NCT06078605	Glaucoma	Nicotinamide(Mi... Placebo	19 Years -	CHA University
Magnetic Resonance Imaging of Patients With Normal Tension Glaucoma	NCT00175786	Normal Tension ...		18 Years -	University of British Columbia
Magnetic Resonance Imaging of Patients With Normal Tension Glaucoma	NCT00175786	Normal Tension ...		18 Years -	University of British Columbia
A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101	NCT04947124	Sturge-Weber Sy... Glaucoma Glaucoma Congen... Ocular Hyperten...	QLS-101ophthalm... QLS-101ophthalm...	18 Years -	Qlaris Bio, Inc.
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients	NCT06078605	Glaucoma	Nicotinamide(Mi... Placebo	19 Years -	CHA University
Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome	NCT04735601	Glaucoma	Ahmed Valve	18 Years -	Sohag University
Relationship Between Eye Pressure and Ganglion Cell Function in Eyes Receiving Latanoprost Versus Placebo	NCT01042665	Glaucoma	latanoprost 0.0... Placebo	18 Years - 85 Years	University of Miami

Spots Global Cancer Trial Database for glaucoma

Every month we try and update this database with for glaucoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for glaucoma

Every month we try and update this database with for glaucoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for glaucoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.