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

Primary Purpose

Degeneration of Macula and Posterior Pole

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Osias Francisco de Souza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Degeneration of Macula and Posterior Pole focused on measuring dmri, mnvc, lucentis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Médico Oftalmológico

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 16, 2012
Last Updated
August 20, 2012
Sponsor
Osias Francisco de Souza
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1. Study Identification

Unique Protocol Identification Number
NCT01669447
Brief Title
Evaluation of Changes in the Parameters of Optical Coherence Tomography After Intravitreal Injection of Lucentis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Osias Francisco de Souza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degeneration of Macula and Posterior Pole
Keywords
dmri, mnvc, lucentis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
LUCENTIS®
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OSIAS SOUZA, PI
Phone
+55(19)97732770
Email
osiasfs@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
NICOLLE ALMEIDA, CO-PI
Phone
+55(19)96867216
Email
nkaalmeida@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NICOLLE ALMEIDA, GRADUATE
Organizational Affiliation
CENTRO MÉDICO OFTALMOLÓGICO
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Osias Souza, PI
Organizational Affiliation
CENTRO MEDICO OFTALMOLÓGICO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia Viana, graduate
Organizational Affiliation
Centro Medico Oftalmológico
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Médico Oftalmológico
City
Campinas
State/Province
SP
ZIP/Postal Code
13092132
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OSIAS SOUZA, PI
Phone
+55(19)97732770
Email
osiasfs@uol.com.br
First Name & Middle Initial & Last Name & Degree
NICOLLE ALMEIDA, SUB-I
Phone
+55(19)96867216
Email
nkaalmeida@gmail.com
First Name & Middle Initial & Last Name & Degree
OSIAS SOUZA, PI
First Name & Middle Initial & Last Name & Degree
NICOLLE ALMEIDA, GRADUATE

12. IPD Sharing Statement

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

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