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Recurrent Pterygium clinical trials

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NCT ID: NCT02530801 Active, not recruiting - Recurrent Pterygium Clinical Trials

Strategies for Management of Recurrent Pterygium

Start date: January 2017
Phase: Phase 4
Study type: Interventional

Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by causing astigmatism and may encroach on cornea (transparent part of the eye) affecting vision. It could cause ocular irritation and can be cosmetically unacceptable especially when inflamed. Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of your eye), before advancing on to the cornea. Treating the recurrent pterygium before the cornea gets involved avoids repeat surgery, which is difficult and is associated with more scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be stopped before it progresses to true recurrence. Several studies attributed the recurrence pf pterygium to the increase of substances as vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF) and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF and fibroblast growth factor. Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring pterygium has been both safe and effective in treatment of recurrent pterygium. In many cases, vascularization and inflammation were controlled by subconjunctival Avastin, providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in ophthalmology because of its anti-scarring properties. The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a challenging condition that usually resists conventional surgery and its rate of recurrence after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by scarring, more risk of intra and post- complications This study aims to generate data to inform further studies towards establishing Avastin and 5 fluouracil as treatment modality for recurrent pterygium.

NCT ID: NCT02486484 Recruiting - Clinical trials for Diabetic Retinopathy

Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection

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: NCT02059837 Completed - Recurrent Pterygium Clinical Trials

Clinical Analysis of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery

Start date: February 2009
Phase: N/A
Study type: Observational

This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft.

NCT ID: NCT02007174 Completed - Recurrent Pterygium Clinical Trials

Bevacizumab Injection for Recurrent Pterygium

Start date: March 2012
Phase: N/A
Study type: Observational

Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to treat abnormal vascular conditions of the anterior segment of the eye. In pterygium, anti-VEGF agents have been recently proposed as primary treatments, such as perioperative adjuvants, as well as treatments for pterygia recurrences after surgery. The aim of the present study was to prospectively evaluate the effect of three subconjunctival bevacizumab injections in patients with an early pterygium recurrence. Materials and Methods: The current study was a non-randomized single central trial. The method of ensuring allocation concealment was sequentially numbered. Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included. Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women were excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were photographed at the third, sixth and twelfth months after the last bevacizumab injection. Photographic analyses were performed taking into account two pterygium areas: the first measure included only the vessel area in the corneal surface, while the second measure included, both, conjunctival and corneal vessel area (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the lesion.

NCT ID: NCT01744756 Completed - Recurrent Pterygium Clinical Trials

Subconjunctival Bevacizumab and Recurrent Pterygium

Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

NCT ID: NCT01319721 Completed - Recurrent Pterygium Clinical Trials

Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane

Start date: December 2010
Phase: N/A
Study type: Interventional

To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal in patients with recurrent pterygium.