Degeneration of Macula and Posterior PolePhase 4NCT01669447
Evaluation of Changes in the Parameters of Optical Coherence Tomography After Intravitreal Injection of Lucentis
A Phase 4 study testing ranibizumab in people with Degeneration of Macula and Posterior Pole, run by Osias Francisco de Souza at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degeneration of Macula and Posterior Pole
- What is being tested?
- ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Médico Oftalmológico
Campinas, São Paulo, 13092132
OSIAS SOUZA, PI, +55(19)97732770, osiasfs@uol.com.br
NICOLLE ALMEIDA, SUB-I, +55(19)96867216, nkaalmeida@gmail.com
About this study
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.
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.
Read the 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.
- Being tested
- ranibizumab
- Keywords
- dmri, mnvc, lucentis
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabBiological
Also called LUCENTIS®
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.
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | 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. Receives: Biological: ranibizumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration of Macula and Posterior PoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osias Francisco de Souza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osias Francisco de Souza, University of Campinas, Brazil
- Investigators
- NICOLLE ALMEIDA, GRADUATE, Study director, CENTRO MÉDICO OFTALMOLÓGICOOsias Souza, PI, Principal investigator, CENTRO MEDICO OFTALMOLÓGICOClaudia Viana, graduate, Study chair, Centro Medico Oftalmológico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669447
- Sponsor's protocol ID
- OSouza
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01669447
- Acronym / sponsor ID
- OSouza
- Keywords
- dmri, mnvc, lucentis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Osias Francisco de SouzaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Biological: ranibizumabInterventional 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: LUCENTIS®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 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NICOLLE ALMEIDA, GRADUATE study director
CENTRO MÉDICO OFTALMOLÓGICO
Osias Souza, PI principal investigator
CENTRO MEDICO OFTALMOLÓGICO
Claudia Viana, graduate study chair
Centro Medico Oftalmológico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ranibizumab in people with Degeneration of Macula and Posterior Pole, run by Osias Francisco de Souza at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OSIAS SOUZA, PI (+55(19)97732770, osiasfs@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.