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Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents and Age Related Macular Degeneration Complications

NCT02557451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-02-09

No results posted yet for this study

Summary

AMD is a disease of the central retina, a zone that enables fine detail activities (reading, detail…). This central zone of the retina can be affected by a haemorrhagic complication when small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic approaches are currently available even though they have never been truly compared. The study will be proposed to patients who need to be treated for haemorrhage of the macula. A certain number of factors will be evaluated to compare the 2 principal approaches currently used in France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled trial to compare these 2 therapeutic approaches.

These diametrically opposed approaches have very different consequences for patients and in terms of cost for society. The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life, while taking into account the risks inherent to these 2 treatments. The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease, which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas.

Conditions

  • Subretinal Haematoma Linked to AMD

Interventions

OTHER

Surgery

OTHER

Intravitreal injections of gas

PROCEDURE

injections of an antiangiogenic

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-28
Primary Completion
2020-05-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02557451 on ClinicalTrials.gov