Study of Nutritional Supplementation in Patients With Unilateral Wet AMD

NCT04756310 | Completed

• 1 other identifier: THEA_UNAV_1/14
• Study Type: interventional
• Target: 109
• Locations: 2 countries
• Sites: 9

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 individuals over 55 years of age. Late AMD, the most severe presentation of the disease, clinically manifests as either geographic atrophy (dry form) or choroidal neovascularization (CNV) (wet form). Although patients with wet AMD only represent 10% of the total cases, CNV is the main and most serious cause of central vision loss. At present, the treatment of wet AMD comprises intraocular injections of certain antiangiogenic agents which act by blocking VEGF (vascular endothelial growth factor). No effective treatment is yet available for dry AMD, though the AREDS (Age-Related Eye Disease Study) has shown that the administration of antioxidant supplements is able to slow progression of the disease. Such vitamin supplements are also indicated in patients who already have severe AMD (both exudative and atrophic) in one eye, since the risk of progression in these cases is high. Recent studies involving new antioxidant and antiangiogenic molecules such as resveratrol, present in grapes and wine, have also revealed great efficacy in slowing the progression of advanced AMD. Hydroxytyrosol is another polyphenol with important antioxidant and antiinflammatory effects in the RPE. Considering the above, the present randomized, multicenter interventional study involving Spanish and Portuguese patients with unilateral wet AMD was designed to compare the effects of two different nutritional supplements: one containing the antioxidants and minerals recommended by the AREDS at doses that can be used in the European Union (Theavit), and the other comprising these same substances plus omega-3 fatty acids (lipidic antioxidant), lutein (pigment protecting against light-induced damage) and resveratrol (antioxidant and antiangiogenic agent) (Retilut).

Conditions

Wet Macular Degeneration

Keywords

AMD; Food Supplement; Antioxidant effect; Antiangiogenic effect; resveratrol

Outcome Measures

Primary Outcomes (2)

• Best correct visual acuity (BCVA)

  Variation in BCVA in the studied eye.

  Comparison will be made of best visual acuity recorded in Month 12 versus that recorded on the baseline visit (Day 0).

• Best correct visual acuity (BCVA)

  Variation in BCVA in the studied eye.

  Comparison will be made of best visual acuity recorded in Month 24 versus that recorded on the baseline visit (Day 0).

Secondary Outcomes (7)

• Inflammatory markers

  Determination will be made of the mean values obtained on visits Month 12 with respect to the recorded baseline values on visit Day 0

• Lipid blood profile

  Determination will be made of the mean values obtained on visits Month 12 with respect to the recorded baseline values on visit Day 0

• Lipid blood profile

  Determination will be made of the mean values obtained on visits Month 24 with respect to the recorded baseline values on visit Day 0

• Carotenoid profile

  Determination will be made of the mean values obtained on visits Month 12 with respect to the recorded baseline values on visit Day 0

• Carotenoid profile

  Determination will be made of the mean values obtained on visits Month 24 with respect to the recorded baseline values on visit Day 0

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients receiving Theavit food supplement considered as a placebo treatment for AMD condition. Two capsules/day before breakfast each day for 2 years

Dietary Supplement: Theavit

Retilut

EXPERIMENTAL

Patients receiving Retilut food supplement. Two capsules/day before breakfast each day for 2 years

Dietary Supplement: Retilut

Interventions

Retilut DIETARY_SUPPLEMENT

antioxidants, antiangiogenic, antiinflammatory micronutrients

Retilut

Theavit DIETARY_SUPPLEMENT

antioxidants micronutrients

Also known as: food supplement

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Thea, Spain: lead
• Alpha Bioresearch S.L.: collaborator
• Investigación Estadística: collaborator

Study Sites (9)

AIBILI

Celas, Coimbra District, 3000-548, Portugal

Location

Instituto de Retina e Diabetes Ocular de Lisboa (IRL)

Lisbon, 1050-085, Portugal

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Miguel Servet University Hospital

Zaragoza, Aragon, 50009, Spain

Location

Hospital Dos de Maig

Barcelona, Catalonia, 08025, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d´Hebrón

Barcelona, 08035, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Policlínico Universitario La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alfredo García-Layana, MD

  Clínica Universidad de Navarra

  STUDY DIRECTOR

• Roberto Gallego-Pinazo, MD

  Hospital Universitario Politécnico La Fe

  PRINCIPAL INVESTIGATOR

• Emiliano Hernández-Galilea, MD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Miguel Ángel Zapata-Victori, MD

  Hospital Universitario Vall d´Hebron

  PRINCIPAL INVESTIGATOR

• Maximino Abraldes, MD, PhD

  Complexo Hospitalario Universitario de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Rufino Silva, MD, PhD,FEBO

  Association for Innovation and Biomedical Research on Light and Image

  STUDY DIRECTOR

• Joao Nascimento, MD

  Instituto de Retina e Diabetes Ocular de Lisboa

  PRINCIPAL INVESTIGATOR

• Jose J Escobar-Barranco, MD

  Hospital Dos de Maig

  PRINCIPAL INVESTIGATOR

• Pilar Calvo, Md, PhD

  Miguel Servet University Hospital, Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: February 16, 2021
• Study Start: November 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

PT (2); ES (7)