Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)

Human Nutrition Research Centers (CRNH)

Status and phase: Completed; Phase 3

Conditions: Age Related Macular Degeneration

Treatments: Dietary Supplement: SOD; Dietary Supplement: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT00800995

CHUG-0501

Details and patient eligibility

About

INTRODUCTION:

Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by increasing the production of H2O2, the administration of SOD can trigger endogenous/internal antioxidant mechanisms.

Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this study was to evaluate the protective effect of SOD on the bilateralization of the disease.

Enrollment: 46 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• unilateral neo-vascular ARMD

Exclusion criteria

• other pathology

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

46 participants in 2 patient groups

Control

Sham Comparator group

Treatment:

Dietary Supplement: Sham

SOD

Experimental group

Treatment:

Dietary Supplement: SOD