Prophylactic Ranibizumab in the fellow eye in patients with wet type Age Related Macular Degeneratio

Phase 3

• Conditions: Wet Age Related Macular Degeneration (AMD); Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12614000511639
• Lead Sponsor: El Gawhara eye center ,Egypt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1- Must be greater than 50 years of age.
2- Must have a good 5-yr prognosis.
3- Must be diagnosed with age-related macular degeneration.
4- Must be likely to be available, willing, and able to undergo examinations at 6-mo intervals for 5 yrs.
5- Must understand and be willing to give signed informed consent.

Exclusion Criteria

General exclusion criteria :
1-Chronic alcoholism or drug abuse.
2- Personality disorder or use of major tranquilizers (e.g., haloperidol,phenothiazine), indicating difficulty in long-term follow-up.
3- Allergy to sodium fluorescein.
Ocular exclusion criteria:
1-For bilateral patients, a BCVA equal to 20/63 on an ETDRS chart in either eye; for unilateral patients, a BCVA equal 20/60 on an ETDRS chart in the eye being considered for treatment.
2- Advanced AMD in either eye for bilateral patients and in both eyes for unilateral patients.
3-A 5 drusen of the specified size within 2250 micron of the center of the fovea in eye(s) being considered for eligibility.
4- Retinopathy due to diabetes mellitus (more than 5 microaneurysms within the temporal Arcades.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the primary outcome represent how the sound eye survived from wet AMD with the aid of intravitreal injection. The eye examined at frequent intervals with optical coherent tomography and fluorescine angiography to found early changes in the retina.[two years follow up of patients with active intervention or no treatment.]

Secondary Outcome Measures

Name	Time	Method
to observe rate of progression of AMD in the sound eye in no treatment group.The eye examined at frequent intervals with optical coherent tomography and fluorescine angiography to found early changes in the retina.[to observe rate of progression of AMD in the sound eye in no treatment group during a follow up of two years.]