- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00801866
Avastin for Post-Photocoagulation Macular Edema
December 3, 2008 updated by: Asociación para Evitar la Ceguera en México
Prevention of Post-Photocoagulation Macular Edema by Intravitreal Bevacizumab.
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DF
-
Mexico, DF, Mexico, 04030
- Asociación Para Evitar la Ceguera en México
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with Proliferative retinopathy or severe non-proliferative retinopathy
- BCVA of 20/63 or better (56 ETDRS letters
- No history of Macular Edema
- Central Retinal Thickness of 250mics or more
Exclusion Criteria:
- Previous treatment.
- Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
- Media opacities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Panretinal Photocoagulation + Bevacizumab
|
Intravitreal administration
|
Experimental: Group 2
Panretinal Photocoagulation
|
Panretinal Photocoagulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Best Corrected Visual Acuity
|
Secondary Outcome Measures
Outcome Measure |
---|
Central Retinal Thickness.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Eduarto Torres-Porras, MD, Asociación Para Evitar la Ceguera en México
- Principal Investigator: Octavio Burgos, MD, Asociación Para Evitar la Ceguera en México
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 3, 2008
First Submitted That Met QC Criteria
December 3, 2008
First Posted (Estimate)
December 4, 2008
Study Record Updates
Last Update Posted (Estimate)
December 4, 2008
Last Update Submitted That Met QC Criteria
December 3, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APEC-035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Macular Edema
-
Federico II UniversityCompletedPseudophakic Cystoid Macular Edema
-
California Retina ConsultantsRegeneron PharmaceuticalsCompletedDiabetic Macular Edema | Cystoid Macular EdemaUnited States
-
Postgraduate Institute of Medical Education and...CompletedDiabetic Macular Edema | Vision Disorders | Macular Edema, Cystoid | Clinically Significant Macular EdemaIndia
-
OcugenNot yet recruitingDiabetic Macular Edema | Center Involved Diabetic Macular Edema
-
Vitreo-Retinal Associates, MichiganVan Andel Research InstituteCompletedDiabetic Macular Edema | Exudative Macular DegenerationUnited States
-
University of OklahomaCompletedAge-Related Macular Degeneration | Diabetic Macular Edema | Intravitreal Injection | Ocular Rinse | Cystoid Macular EdemaUnited States
-
OculisICON plcRecruitingDiabetic Macular EdemaUnited States
-
Novartis PharmaceuticalsNot yet recruiting
-
Hoffmann-La RocheRecruitingUveitic Macular EdemaKorea, Republic of, United Kingdom, China, United States, Netherlands, Canada, Israel, Austria, Brazil, Italy, Taiwan, Poland, Portugal, Mexico
-
Vista KlinikNot yet recruitingDiabetic Macular Edema
Clinical Trials on Bevacizumab
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterRecruitingStage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8United States
-
National Cancer Institute (NCI)Active, not recruitingOvarian Endometrioid Adenocarcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Ovarian High Grade Serous Adenocarcinoma | Platinum-Resistant... and other conditionsUnited States, Canada
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7United States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditionsUnited States