PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

Primary objective:

To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR).

Primary outcome:

The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48.

Secondary objectives:

• To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48.

• To assess the incidence of adverse events during the study.

Strategic goal:

In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Diabetic patients older than 18 years

2. Presence of PDR (presence of retinal neovascularization, defined as active neovessels (fine retinal vessels with saccular dilatations or extremities covered with blood or associated with recurrent vitreous hemorrhage) with visual acuity better than 20/800 and with no previous laser treatment

3. Giving written informed consent.

Exclusion Criteria:

1. Presence of advanced PDR, i.e.: vitreous hemorrhage that would prevent documentation of the eye fundus or adequate retinal photocoagulation, or presence of traction retinal detachment

2. Presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc

3. Any abnormality of the vitreoretinal interface in the macular region for which the investigator would consider vitrectomy via pars plana to be necessary

4. Intravitreous injection of corticosteroids or of other antiangiogenic drugs 6 months before the evaluation for entry into the study

5. Inability to fixate and to conclude the automated static perimetry exam

6. Cataract surgery within the last three months

7. Posterior vitrectomy with scleral introflexion at any time

8. Acute ocular infection

9. Allerghy to fluorescein

10. Medical or psychological conditions that would prevent the patient from giving informed consent and concluding the study

11. Significant uncontrolled diseases which, in the opinion of the investigator, would exclude the patient from the study

12. Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels >2.0 mg/dl

13. Untreated diabetes mellitus

14. Severe (blood pressure systolic > 160 mmHg or diastolic > 100 mmHg) AND untreated hypertension

15. Inability to comply with study or follow-up procedures.

16. Impaired or limited legal capacity

17. Participation in another clinical study in the last 30 days.