None listed
Conditions
Brief summary
1. To study the effect of intra vitreal injection of Prophylactic Ranibizumab on the development of wet type AMD in the eye with drusens in patients with preexisting neovascular AMD in the fellow eye. 2. To study the progression of drusens in the eye of patients with preexisting neovascular AMD in the fellow eye when no Treatment is given. 3. To compare between the progression drusens in the eye of patients with preexisting neovascular AMD in the fellow eye either when prophylactic Ranibizumab is injected intravitreally or with no treatment.
Interventions
Ranibizumab injection is a prescription medicine for the treatment of patients with neovascular (wet) AMD with satisfactory results, our clinical observation is that once the eye enter wet AMD it will never regain best corrected visual acuity like before the disease process so if we can use ranibizumab injection as a prophylactic in the sound eye in patient suffering from manifestations of Wet AMD in the other eye, it will be a good achievement.
Ranibizumab is injected intravitreally with a dose
Ranibizumab injection is a prescription medicine for the treatment of patients with neovascular (wet) AMD with satisfactory results, our clinical observation is that once the eye enter wet AMD it will never regain best corrected visual acuity like before the disease process so if we can use ranibizumab injection as a prophylactic in the sound eye in patient suffering from manifestations of Wet AMD in the other eye, it will be a good achievement. Ranibizumab is injected intravitreally with a dose of 6 mg/mL LUCENTIS (0.3 mg dose vial).injection applied 3 times (one every six months). the follow up for two years. The progression of the disease is monitored with two investigations 1- fluorescine angiography. 2- optical coherence tomography
Sponsors
El Gawhara eye center ,Egypt
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed