Status:
COMPLETED
Study of Nutritional Supplementation in Patients With Unilateral Wet AMD
Lead Sponsor:
Laboratorios Thea, Spain
Collaborating Sponsors:
Alpha Bioresearch S.L.
Investigación Estadística
Conditions:
Wet Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Retinal diseases are currently the leading cause of legal blindness in the developed world. Among these disorders, age-related macular degeneration (AMD) is one of the most prevalent conditions in ind...
Detailed Description
Retinal diseases are currently the leading cause of legal blindness in the developed world. Among these disorders, age-related macular degeneration (AMD) is one of the most prevalent conditions in ind...
Eligibility Criteria
Inclusion
- Men or women aged ≥ 50 years.
- Presence of unilateral choroidal neovascularisation or any of its clinical manifestations, such as disciform scars, subretinal hemorrhage, retinal pigment epithelium detachment associated to subretinal fluid and/or subretinal hemorrhage (stage V of the modified AREDS classification; AREDS, J.M. Seddon; IOVS 2009).
- Patients who understand the conditions and particularities of the study and have given their written informed consent to participation in the trial.
Exclusion
- Patients with myopia \> 6 dioptres.
- Presence of posterior pole anomalies which can give rise to choroidal neovascularisation: nevi, angioid streaks, central serous choroidopathy, heredodegenerative retinal diseases, myopic choroidosis, diabetic retinopathy and choroiditis.
- Media opacification precluding adequate assessment of the ocular fundus.
- Patients who in the opinion of the investigator are very likely to not be able or not want to continue participating in the study.
- Women of child-bearing potential who do not use a medically acceptable and highly effective contraceptive method (i.e., hormone implants, oral or parenteral contraceptives, together with condoms, certain intrauterine devices) from the inclusion visit and throughout the study treatment periods, up until two weeks after the study. Postmenopausal women (two years without menstruation) require no contraceptive method.
- Patients having participated in any other treatment efficacy protocol in the previous three months.
- Patients who will be participating in any other treatment efficacy protocol concomitant to the present study.
- Patients using any type of nutritional supplement in the month before the screening visit.
- Suspected or confirmed illegal drug abuse.
- Incapacity of the patient and/or relatives to understand the study procedures, and thus inability to give informed consent.
- Non-compliers, i.e., patients who fail to report to the follow-up visits or whose life style interferes with the protocol.
- Patients under legal custody.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04756310
Start Date
November 1 2014
End Date
April 1 2018
Last Update
February 16 2021
Active Locations (9)
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1
AIBILI
Celas, Coimbra District, Portugal, 3000-548
2
Instituto de Retina e Diabetes Ocular de Lisboa (IRL)
Lisbon, Portugal, 1050-085
3
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
4
Miguel Servet University Hospital
Zaragoza, Aragon, Spain, 50009