Evaluation of Changes in the Parameters of Optical Coherence Tomography After Intravitreal Injection of Lucentis

Study Description

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Brief Summary:

Significant difference in the parameter settings of early optical coherence tomography (OCT spectal domain) in patients with subfoveal neovascular membrane realacionada age after treatment with a single intravitreal injection of Lucentis.

Condition or disease	Intervention/treatment	Phase
Degeneration of Macula and Posterior Pole	Biological: ranibizumab	Phase 4

Detailed Description:

Assessment in early changes in the parameters of optical coherence tomography (OCT spectral domain) in patients with subfoveal neovascularization secondary to age-related degeneration after treatment with a single intravitreal injection of Lucentis.

Age-related macular degeneration (AMD) leading cause of blindness over 50 years in developed Western countries. Its prevalence increases with age affecting about 8.5 to 27.9% of the population over 75 years. Its incidence has increased 30-40% in recent decades, in spite of eye diseases such as cataracts and glaucoma, which reach the same population group, have shown apparently reduced their records.

Although approximately 80% of patients with AMD have the neovascular form does not, the neovascular form is responsible for almost 90% of severe visual loss resulting from AMD. It creates great socioeconomic impact, becoming a public health problem.

Quantitative analysis of OCT has shown increasing clinical importance with the development of anti-VEGF therapy to evaluate the outcome of the treatment of neovascular AMD.

Relatively few studies in AMD has been proposed to examine the correlation between the morphological parameters of the OCT and BCVA in a systematic way.

It is important to assess the impact that different OCT parameters have on visual acuity as early as 7 days after intravitreal injection of ranibizumab in patients with AMD to define which of these parameters correlate better with the AV and prognosis. It is also unknown which patients' perception of the effectiveness of treatment in early stage. For this evaluation, we apply the visual function questionnaire (VFQ - 25) 1 and 7 days after treatment.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Assessment in Early Changes in the Parameters of Optical Coherence Tomography (OCT Spectral Domain) in Patients With Subfoveal Neovascular Membranes Related to Age After Treatment With a Single Intravitreal Injection of Lucentis.
Study Start Date :	September 2012
Estimated Primary Completion Date :	November 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

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Arm

Intervention/treatment

Experimental: ranibizumab; Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320. To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium. Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment.

Biological: ranibizumab; Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320. To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium. Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment.; Other Name: LUCENTIS®

Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male or female> 50 years who signed the consent form BCAV of 20/40 20/320 (Snellen equivalent determined using ETDRS)Have choroidal neovascularization associated with AMD, have lesions involving the fovea assessed using fluorescein angiography and fundus Background of subfoveal choroidal neovascularization from the recent developments have constructive AMD disease, observed by the presence of blood, decrease the AV recent or most recent increase in the diameter range of 10% or more.

Exclusion Criteria:

• Concomitant diseases or eye conditions eye disorders that may confound interpretation of study results affecting visual acuity or require medical surgical interventions during 30 days of the study period, including retinal vascular occlusion,retinal detachment and macular hole. Eye Treatments with laser photocoagulation panretiniana eye studied for 6 months or less or focal / grid photocoagulation in the eye studied for less than 3 months of the entry into the study treatment with anti-angiogenic or intravitreal steroids in the eye studied until 4 months before randomization Any intraocular surgery on the eye studied until 3 months before History randomization vitrectomy eye conditions studied in ocular studied eye requiring concomitant therapy with corticosteroids oral or topical. Condition Treatment or systemic history of disease, metabolic dysfunction, physical examination findings, or laboratory suspected to cause disease or condition that contraindicates the use of study drugs, change the interpretation of the study or place the patient in risk of complications from the treatment. And intractable severe hypertension (diastolic blood pressure> 160 mmHg or diastolic> 100 mmHg) Use of drugs known to be toxic to the lens, retina or optic nerve including Deferoxamine, chloroquine, tamoxifen, fenotiazines, and ethambutol. Known hypersensitivity to ranibizumab or its components prior Administrative Participation of patients in studies clinical investigative drug (excluding vitamins and minerals) at 6 months (or period corresponding to five half-lives of drug investigated is greater) before randomization Failure to comply with study procedures or follow-up

Contacts and Locations

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Contacts

Contact: OSIAS SOUZA, PI	+55(19)97732770	osiasfs@uol.com.br
Contact: NICOLLE ALMEIDA, CO-PI	+55(19)96867216	nkaalmeida@gmail.com

Locations

Brazil
Centro Médico Oftalmológico	Not yet recruiting
Campinas, SP, Brazil, 13092132
Contact: OSIAS SOUZA, PI +55(19)97732770 osiasfs@uol.com.br
Contact: NICOLLE ALMEIDA, SUB-I +55(19)96867216 nkaalmeida@gmail.com
Principal Investigator: OSIAS SOUZA, PI
Sub-Investigator: NICOLLE ALMEIDA, GRADUATE

Sponsors and Collaborators

Osias Francisco de Souza

Investigators

Study Director:	NICOLLE ALMEIDA, GRADUATE	CENTRO MÉDICO OFTALMOLÓGICO
Principal Investigator:	Osias Souza, PI	CENTRO MEDICO OFTALMOLÓGICO
Study Chair:	Claudia Viana, graduate	Centro Medico Oftalmológico

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Osias Francisco de Souza, PhD in Ophthalmology, University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT01669447 History of Changes
Other Study ID Numbers:	OSouza
First Posted:	August 21, 2012
Last Update Posted:	August 21, 2012
Last Verified:	August 2012

Keywords provided by Osias Francisco de Souza, University of Campinas, Brazil:

dmri, mnvc, lucentis

Additional relevant MeSH terms:

Keratoconus; Color Vision Defects; Macular Degeneration; Choroid Diseases; Corneal Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms	Retinal Degeneration; Retinal Diseases; Uveal Diseases; Ranibizumab; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antineoplastic Agents