Methods for treating diabetic retinopathy using brolucizumab
A method is provided for treating a patient having a neovascular ocular disease.
1 . A method for treating proliferative diabetic retinopathy (PDR) in a human patient in need thereof, the method comprising:
a) administering to the patient by intravitreal injection three individual 6 mg doses of brolucizumab at 6-week intervals, followed by
b) administering to the patient by intravitreal injection additional 6 mg doses of brolucizumab according to a maintenance phase comprising a treatment interval that is once every 12 weeks (q12w).
2 . The method of claim 1 , further comprising assessing the patient for PDR disease activity before or after administering each maintenance phase dose.
3 . The method of claim 2 , wherein PDR disease activity is assessed based on identifying best corrected visual acuity (BCVA), ETDRS DRSS score, retinal neovascularization status, and peripheral visual field.
4 . The method of claim 2 , wherein if worsening of PDR disease activity is identified after a q12w dose, the patient is switched to a q6w dose interval.
5 . The method of claim 4 , wherein alternatively if disease activity is stable or improved relative to a prior disease activity assessment, the maintenance phase treatment interval is extended by 6 weeks at a time up to a 24 week treatment interval (q24w).
6 . The method of claim 4 , wherein the worsening of PDR disease activity is new or worsening retinal neovascularization, reperfusion of retinal neovascularization, increase in ETDRS DRSS score, loss in peripheral visual field, and/or developing complications that impact visual acuity compared to any previous assessment.
7 . The method of claim 2 , wherein at any time during the maintenance phase, the treatment interval is extended to 18 weeks (q18w) or 24 weeks (q24w) if PDR disease activity is stable or improved relative to a prior PDR disease activity assessment.
8 . The method of claim 1 , wherein the patient does not have macular edema.
9 . A method for treating diabetic retinopathy (DR) or proliferative diabetic retinopathy (PDR) comprising administering by intravitreal injection to a human patient in need thereof three individual 6 mg doses of brolucizumab at 6-week intervals in a loading phase, followed by additional 6 mg doses of brolucizumab every 12 weeks (q12w) in a maintenance phase.
10 . The method of claim 9 , further comprising assessing the patient's DR or PDR disease activity before or after administering each maintenance phase dose.
11 . The method of claim 10 , wherein DR or PDR disease activity is assessed based on identifying best corrected visual acuity (BCVA), ETDRS DRSS score, retinal neovascularization status, and peripheral visual field.
12 . The method of claim 10 , wherein at any time during the maintenance phase the dosing intervals are extended to 24 weeks (q24w) if DR or PDR disease activity is improved or stable relative to the prior DR or PDR disease activity assessment.
13 . The method of claim 12 , wherein if worsening of DR or PDR disease activity is identified after a q12w dose, the patient is switched to a q6w dose interval.
14 . The method of claim 13 , wherein alternatively if disease activity is stable or improved relative to a prior disease activity assessment, the maintenance phase treatment interval is extended by 6 weeks at a time up to a 24 week treatment interval (q24w).
15 . The method of claim 13 , wherein the worsening of DR or PDR disease activity is new or worsening retinal neovascularization, reperfusion of retinal neovascularization, increase in ETDRS DRSS score, loss in peripheral visual field, and/or developing complications that impact visual acuity compared to any previous assessment.
16 . The method of claim 9 , wherein the patient also has does not have macular edema.
17 . A method for preventing progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) in a human patient in need thereof, the method comprising:
a) administering by intravitreal injection to the patient three individual 6 mg doses of brolucizumab at 6-week intervals; followed by
b) administering by intravitreal injection to the patient additional 6 mg doses of brolucizumab according to a maintenance phase comprising a treatment interval that is once every 12 weeks (q12w).
18 . The method of claim 17 , further comprising assessing the patient for disease activity before or after administering each maintenance dose.
19 . The method of claim 18 , wherein disease activity is assessed based on identifying best corrected visual acuity (BCVA), ETDRS DRSS score, retinal neovascularization status, and peripheral visual field.
20 . The method of claim 18 , wherein if worsening of disease activity is identified after a q12w dose, the patient is switched to a q6w dose interval.
21 . The method of claim 20 , wherein alternatively if disease activity is stable or improved relative to a prior disease activity assessment, the maintenance phase treatment interval is extended by 6 weeks at a time up to a 24 week treatment interval (q24w).
22 . The method of claim 20 , wherein the worsening of disease activity is new or worsening retinal neovascularization, reperfusion of retinal neovascularization, increase in ETDRS DRSS score (such as an increase of 2 or more steps), loss in peripheral visual field, and/or developing complications that impact visual acuity compared to any previous assessment.
23 . The method of claim 18 , wherein if disease activity is stable or improved relative to a prior disease activity assessment, the maintenance phase treatment interval is extended by 6 weeks at a time up to a 24 week treatment interval (q24w).
24 . The method of claim 17 , wherein the patient does not have macular edema.