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Eye Diseases clinical trials

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NCT ID: NCT02157077 Completed - Clinical trials for Macular Degeneration

Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration

ARI2
Start date: December 2013
Phase: Phase 3
Study type: Interventional

The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis. The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.

NCT ID: NCT02155049 Completed - Clinical trials for Thyroid Associated Ophthalmopathies

Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

Start date: November 2014
Phase: Phase 3
Study type: Interventional

Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.

NCT ID: NCT02136940 Completed - Glaucoma Clinical Trials

Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Start date: April 2014
Phase: Phase 2
Study type: Interventional

The objective of this parallel group study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

NCT ID: NCT02120079 Completed - Dry Eye Disease Clinical Trials

The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

Start date: February 2014
Phase: Phase 4
Study type: Interventional

This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball). Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED. Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.

NCT ID: NCT02112643 Withdrawn - Clinical trials for Thyroid Associated Ophthalmopathies

Selenium in Mild Thyroid Eye Disease in North America

S-ITEDS
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether sodium selenite is helpful in the treatment of mild thyroid eye disease in North America.

NCT ID: NCT02111928 Completed - Dry Eye Disease Clinical Trials

NovaTears® Eye Drops Observational Study

Start date: December 2013
Phase: N/A
Study type: Observational

This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

NCT ID: NCT02106377 Recruiting - Dry Eye Syndrome Clinical Trials

Using in Vivo Confocal Microscopy to Assess Cellular Response and Efficacy of Steroid Treatment in Dry Eye Disease

Start date: February 2014
Phase: N/A
Study type: Interventional

Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse therapy, administered twice daily (to avoid adverse effects associated with long-term steroid use). This timeframe is often too short to meaningfully resolve the inflammation associated with DED. Thus, corneal specialists, including here at MEEI, have begun using steroid treatment of at least 6 weeks with tapered dosing. In vivo confocal microscopy (IVCM) is a novel imaging technology that allows the visualization and quantification of certain corneal features associated with DED, such as hyperfluorescent superficial epithelial cells, immune dendritic cells, and sub-basal nerves. Recent cross-sectional studies have begun to shed light on the correlation of these features with traditional outcome measures typically assessed in DED, such as corneal and conjunctival staining, Schirmer's testing, tear break-up time (TBUT), and symptom questionnaires. However, longitudinal studies using IVCM to demonstrate how steroid treatment affects the corneal epithelial cells, dendritic cells and nerves are largely lacking. Furthermore, studies on the safety and efficacy of a 6 week tapered dosing steroid regimen are also lacking.

NCT ID: NCT02089009 Completed - Eye Diseases Clinical Trials

Comparison of Non-mydriatic Camera Systems in a Female Health Hospital

Start date: December 2013
Phase: N/A
Study type: Interventional

1. To compare quality and usability of images taken by two different camera-systems without dilating the pupil. 2. To compare the retinal vessel diameters based on the images of to different camera-systems. 3. To detect changes in retinal vessel diameters while pregnancy and after delivery.

NCT ID: NCT02077894 Recruiting - Genetic Eye Disease Clinical Trials

Whole Exome and Whole Genome Sequencing for Genotyping of Inherited and Congenital Eye Conditions

Start date: August 5, 2014
Phase:
Study type: Observational

Objective: The objective of this study is to identify genetic causes of inherited eye conditions through whole exome or whole genome sequencing. This includes identifying mutations in known genes or novel genes for recognized conditions, as well as identifying mutations in novel genes for previously uncharacterized genetic conditions involving the eye. Study Population: We plan to recruit 1,685 participants, to include both participants with an eye condition under study and unaffected family members. Ideally unaffected family members will be parents of an affected participant. Design: Most affected participants will be recruited from existing studies at the NEI. These include, but are not limited to, the Screening Protocol (08-EI-0102), the NEI Ocular Natural History protocol (16-EI-0134), the Genetics of Inherited Eye Disease protocol (15-EI-0128) and the Pathogenesis and Genetics of Microphthalmia, Anophthalmia and Uveal Coloboma (MAC) study (13-EI-0049). Unaffected family members will be invited to participate once an affected relative is determined eligible for participation. Offsite affected and unaffected participants will also be enrolled. If a participant is self-referred or referred to the study by an outside provider, screening will determine whether participation is offered. Offsite participants will be screened via phone or secure videoconference, and records will be requested for evaluation of affected participants.. Both affected and unaffected eligible participants will undergo genetic counseling and will provide a blood sample and/or saliva sample for exome or genome sequencing. Biological relationships may be confirmed prior to exome or genome sequencing. Sequence data will be analyzed for primary variants and secondary findings, unless participants choose to opt-out of secondary analysis and reporting. All sequence variants deemed clinically relevant will be validated in a CLIA-certified laboratory and the results will be returned to the participant in-person, secure video conference, or by telephone. Outcome Measures: This is an etiologic study that will generate molecular information about previously-recognized conditions for which participants did not have a molecular diagnosis, as well as molecular information for previously uncharacterized conditions involving the eye.

NCT ID: NCT02059655 Completed - Clinical trials for Graves' Ophthalmopathy

Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)

BIMA
Start date: November 2014
Phase: Phase 4
Study type: Interventional

The purpose of the study is to establish whether Bimatoprost eye drops are effective in reducing proptosis in inactive thyroid eye disease (TED) patients and improving quality of life in patients with TED. Current standard NHS treatment/care for inactive TED is artificial tears (used as the placebo in this study) or surgery if appropriate. The IMP is Bimatoprost eye drops PGF2α (0.03%). This is already licensed eye drops usually used for glaucoma. Therefore the current trial's indication is outside its licenced indication. The Investigational Medicinal Product (IMP) will be used according to its licenced dosage and form. This is the first time that Bimatoprost will be used in the treatment of TED