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Choroidal Neovascularization clinical trials

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NCT ID: NCT02486484 Recruiting - Clinical trials for Diabetic Retinopathy

Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection

Zaltrap
Start date: March 2015
Phase: Phase 2
Study type: Interventional

Background/aims: Aflibercept is an approved therapy for neovascular macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion and other retinal conditions. Ziv-aflibercept is also approved by FDA and is extremely cost-effective relative to the expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept. Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous saving compared to aflibercept or ranibizumab. Phase I studies and case reports did not report any untoward toxic effects but attested to the clinical efficacy of the medication. Our purpose is to ascertain the long-term safety and efficacy in various retinal diseases of intravitreal ziv-aflibercept. Methods: Prospectively, consecutive patients with retinal disease that require aflibercept (AMD, DME, RVO, and others) will undergo instead the same molecule ziv-aflibercept intravitreal injection of 0.05 ml of fresh filtered ziv-aflibercept (1.25mg). Monitoring of best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal structure by spectral domain OCT to be done initially, one month, 6 months, 1 year, and 2 years after injections. Anticipated Results: Analyze signs of retinal toxicity, intraocular inflammation, or change in lens status, together with best corrected visual acuity and central foveal thickness at 1 month, 6 months, 1 year and 2 year. Anticipated Conclusions: Off label use of ziv-aflibercept improves visual acuity without ocular toxicity and offers a cheaper alternative to the same molecule aflibercept (or lucentis), especially in the third world similar to bevacizumab.

NCT ID: NCT02092532 Recruiting - Clinical trials for Neovascular Polypoidal Choroidal Vasculopathy

Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy (RIVAL Trial)

RIVAL
Start date: March 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.

NCT ID: NCT02033018 Recruiting - Clinical trials for Choroidal Retinal Neovascularization

Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

AflibxMyopia
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary

NCT ID: NCT01790893 Recruiting - Clinical trials for Ocular Histoplasmosis

Treatment for Presumed Ocular Histoplasmosis

HANDLE
Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.

NCT ID: NCT01521065 Recruiting - Clinical trials for Age-Related Macular Degeneration

An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

ENDEAVOUR
Start date: September 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).

NCT ID: NCT00855608 Recruiting - Clinical trials for Diabetic Retinopathy

Intravitreal Adalimumab in Refractory Diabetic Retinopathy, Choroidal Neovascularization or Uveitis: A Pilot Study

ADA01
Start date: March 2009
Phase: Phase 1
Study type: Interventional

Direct intravitreal administration of medication is the preferred method of treatment for uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug levels can be achieved with a much smaller amount of medication if injected intravitreally and this also results in minimal systemic exposure to the patient. Preliminary studies have shown that adalimumab may have a positive role in the management of uveitis in humans and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of adalimumab in human subjects.

NCT ID: NCT00568191 Recruiting - Clinical trials for Age-Related Macular Degeneration

Stratus Versus Cirrus OCT in AMD

Start date: October 2007
Phase: N/A
Study type: Observational

The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected

NCT ID: NCT00260403 Recruiting - Clinical trials for Choroidal Neovascularization

TTT Versus PDT for Treatment of Choroidal Neovascularization in Age-Related Macular Degeneration

Start date: June 2003
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to compare photodynamic therapy to transpupillary thermotherapy as a treatment method for choroidal neovascularization in age-related macular degeneration ( AMD). AMD is a disease affecting the macula, the central area of the retina.There are two main types of AMD. Geographic atrophy ( dry) AMD and neovascular ( wet) AMD. In neovascular AMD, sub-retinal neovascular membranes ( new blood vessels) develop beneath the retina. The new vessels can leak causing haemorrhage that leads to significant visual loss. Photodynamic therapy ( PDT) is a method for treating neovascular membranes without affecting the retina. Photoactive chemicals are injected into the patient and irradiated with light as the pass through the neovascular membranes. This light is strong enough to activate the chemicals, that destroy the blood vessels, but not strong enough to cause damage to the overlying retina. The duration of the treatment is 83s. PDT treatment is effective in predominantly classic subfoveal choroidal neovascularization ( CNV), but was observed to yield no visual benefit in minimally classic CNV during a 2-year follow-up and as to occult CNV the effect was scarce. PDT does have its drawbacks, one of which is the cost. Another is that the patient become highly sensitive to strong light. Transpupillary thermotherapy ( TTT) is a thermic treatment of choroidal neovascularization in AMD. Using a thermal diode laser ( emission 810 nm), transpupillary irradiation of the fundus through a conventinal contact lens is performed. The temperature is elevated < 10 degrees C during a 60s exposure to continuous radiation. The laser power is adjusted to the diameter of the laser beam. In a pilot study, Reichel et al. ( 1999) demonstrated that subfoveal occult CNV could be occluded and visual acuity stabilized in a majority of patients treated with TTT. These results has been confirmed in small series of cases with occult CNV and with minimally ( <50%) classic CNV. This prospective, randomized controlled study aim to compare TTT and PDT as a treatment for occult and minimally classic CNV. A total of 140 patients will be included in the study. Follow up is 2 years. The patients included will be followed as to visual acutiy ( ETDRS), new vessel growth ( fluorescien angiography and ICG), OCT and with a quality of life questionnarie.

NCT ID: NCT00157976 Recruiting - Clinical trials for Macular Degeneration

Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).

NCT ID: NCT00100087 Recruiting - Clinical trials for Macular Degeneration

Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System

Start date: October 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The study will investigate the safety and feasibility of using the TheraSight(TM) Brachytherapy System for treatment of wet age-related macular degeneration (AMD).