CLINICAL TRIALS

SPONTANEOUS STUDIES

  1. Pegaptanib in diabetic macular edema. Perspective study, open for 12 months.
  2. Observation study on morfo-functional alterations in early AMD and intermediate AMD
  3. Observation study on functional and morphological modifications of lamellar macular holes
  4. Macular oedema treatment secondary to central or branch vein occlusion by intravitreal injection of dexamethasone (Ozurdex)
  5. Detection of retinal disease progression in eyes with Non Proliferating Diabetic Retinopathy (RDNP) in patients with type 2 diabetes using non-invasive procedures
  6. Observation study on morphological changes in choroid in patients with high myopia
  7. Evaluation of the role of aldosterone on arterial rigidity and microcirculation in a non-invasive way through the use of both arteriograph and static vessel analyzer in pcs with primary hyperaldosteronism compared to essential hypertensive subjects and healthy subjects.
  8. Role of the Matrix perimeter in the long-term follow-up of patients with type 1 diabetes


SPONSORED CLINICAL TRIALS

1.    A six-month, phase 3, multicenter, masked, randomized, sham-controlled trial (with six-month open label extension) to assess the safety and efficacy of 700 and 350 Dexamethasone Posterior segment Drug delivery System (DEXPSDDS) Applicator System in the treatment of patients with macular edema following central retinal vein occlusion or branch vein occlusion. (GENEVA)

2.    Phase 3, multicentric, blind, randomized, and placebo-controlled three-year study  to assess the safety and efficacy of 700 µg and350 µg  of slow-release dexametazone in the treatment of patients with diabetic macular edema. (MEAD)

3.   Phase 3, randomized, double-blind, active-control study on the efficacy, safety, and tolerability of the repeated intravitreal administration of VEGF-Trap in patients with macular degeneration tied to neovascular age. (VIEW2)

4.    Phase 2, prospective, randomized, blind, multicentric, dose-ranging comparison study PF-04523655 regarding laser treatment in patients with diabetic macular edema. (DEGAS)

5.    Phase 3, randomized, double-blind, placebo-controlled study on the efficacy, safety, and tolerability of the repeated intravitreal administration of VEGF-Trap in patients with macular degeneration secondary to central retinal vein occlusion. (GALILEO)

6.    Study C-09-003. Phase 3b, prospective, multicentric, double-blind, randomized, controlled study to assess the efficacy and safety of  NEVANAC (nepafenac ophthalmic suspension) 0.1% versus placebo (vehicle) after cataract surgery in patients with diabetic retinopathy.

7.   Study on the efficacy and safety of ranibizumab 0.5 mg (Lucentis) in patients with diabetic macular edema.

8.   Phase 2, multicentric, randomized, controlled, double-blind, parallel-group six-month study to assess the safety and effectiveness of the topical administration of two different concentrations of FOV2304 (1% and 2%) BID for the treatment of cystoid macular edema associated with diabetic retinopathy (FOVEA)

9.   Phase 3, randomized, double-blind, active-control study on the safety and efficacy of repeated doses of VEGF-Trap in patients with diabetic macular edema. (VIVID)

10. A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare the Efficacy and Safety of Ozurdex® Versus Lucentis® in Patients with Branch Retinal Vein Occlusion (COMO).

11. A multicenter, open-label, randomized study comparing the efficacy and safety of 700 mg Dexamethasone posterior segment drug delivery system (DEX PS DDS) to ranibizumab in patients with diabetic macular edema.

12.   A non-interventional study in patients with diabetic macula edema (DME) with central involvement to assess the effectiveness of existing anti vascular endothelial growth factor (anti-VEGF) treatment regimens (POLARIS).

13. Prospective, randomized, multicentre, open label, phase II / III study to assess efficacy and safety of ranibizumab 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus PRP in monotherapy in the treatment of subjects with high risk proliferative diabetic retinopathy. (PROTEUS).

14.   A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven choroidal neovascularization (CNV) (MINERVA).

15. A 12 months, open-label, interventional, multicentre study to investigate the current criteria driving re-treatment with ranibizumab upon relapse in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia.

16.   A 12-month, phase IIIb, randomized, single-masked, multicenter study assessing the efficacy and safety of ranibizumab 0.5mg in Treat and Extend regimen compared to Monthly regimen, in patients with neovascular agerelated macular degeneration (TREND).

17. A phase 3 randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista™ (Anti PDGF-B pegylated aptamer) administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal neovascular age-related macular degeneration (FOVISTA).

18. A Phase 4, multi-center, prospective, single-arm, open-label study to assess ocriplasmin effectiveness in subjects treated with a single intravitreal injection of ocriplasmin 0.125 mg as treatment for VMT/sVMA. (JETREA)

19. A Collaborative Retrospective Trial on the Efficacy and Safety of intravitreal dexamethasone implant (Ozurdex) in patients with Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES).

20.  Safety and Efficacy of Abicipar Pegol in Patients with Neovascular Age-related Macular Degeneration (DARPin) (SEQUOIA)

21.  A 12 months, open-label, interventional, multicentre study to investigate the current criteria driving re-treatment with ranibizumab upon relapse in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (OLIMPIC)

22. A phase III, multicerter, randomized, double-masked, sham-controlled, study of efficacy and safety of 10 mg lampalizumab intravitreal injections administered every 30 or 45 days to patients with geographic atrophy secondary to age-related macular degeneration (CHROMA)

23. A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With BCVA Below 2/10 and/or Second Affected Eye (TWEYES)

24. Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)