An interventional study of Ranibizumab in Wet Macular Degeneration and Cataract Extraction, sponsored by Ophthalmica Eye Institute. Status unknown at 1 site in Greece. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by Ophthalmica Eye Institute · Not applicable, Interventional, and Treatment
To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.
To-date there have been only very few studies to examine the effect of cataract surgery to patients with neovascular age-related macular degeneration (AMD), especially in the era of anti-vascular endothelial growth factor (anti-VEGF) therapy. Furthermore the issue of optimum treatment regimen that should be used in the peroperative period has never been addressed. Since the human life expectancy gradually increases, the number of patients who are under anti-VEGF intravitreal injections for wet AMD will be increasing accordingly. Cataract surgery in such patients, despite guarded prognosis has been proved to improve their visual function and quality of life. On the other hand, it has been shown that cataract surgery induces anatomic changes based on optical coherence tomography analysis, suggesting a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 16 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Ophthalmica Eye Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
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The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.
Drug: Ranibizumab
The participants will continue their preoperative treat and extend protocol .
Drug: Ranibizumab
Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.
Also known as: Lucentis
Visual acuity change from baseline
Difference in visual acuity change from baseline at the end of the follow-up period.
Time frame: 12 months
Difference in the number of injections
Difference in the number of injections at the end of the follow-up period.
Time frame: 12 months
Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline
The status of the age-related macular degeneration will be evaluated based on optical coherence tomography parameters at the at final follow-up and compared to the baseline. Our main focus is to identify any subfoveal scarring and/ or subfoveal atrophy that may develop during the follow-up and assess changes from the baseline state of the macula.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Ophthalmica Eye Institute